6/2/2017
MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC
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MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC |Adverse |Recalls11 |PMA12|HDE13|Classification14|Standards15 6510(k) 7|DeNovo8|Registration & 9 10 Listing Events CFR Title 2116 |RadiationEmitting Products17|XRay Assembler 18|Medsun Reports19|CLIA20|TPLC21
ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC Back to Search Results Catalog Number PHY2025V Device Problem Migration of device or device component Event Type Injury Event Description It was reported that the patient underwent a lap abdominal incisional hernia procedure on an unknown date and mesh was implanted. In (b)(6) 2015, it was found that recurrence of hernia occurred before the patient was discharged from the hospital. Reoperation was performed soon after the recurrence was first noted. In the reoperation, the mesh which had been used in the initial operation was not found inside the patient and the size of hernia was quite large. A competitive mesh was used in the reoperation and there was no problem. The condition of the patient at the time is unknown. Additional information has been requested. Manufacturer Narrative (b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The patient demographic info: age, gender, weight, bmi at the time of index procedure to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. Manufacturer Narrative Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure no information. What were current symptoms following the index surgical procedure? onset date? no information. Date of initial surgical procedure? (b)(6) 2015. Date that the surgeon first noted hernia recurrence? soon after the operation before the patient was in hospital. What is meant by mesh was not found? for example, was the mesh not incorporated in the tissue? when the reoperation was done, the surgeon cannot find the mesh. Other relevant patient history/concomitant medications no information. What is physicians opinion as to the etiology of or contributing factors to this event? no information. Was the hernia repair associated with this event performed on primary or recurrent hernia? primary. Mesh size and overlap? no information. In what tissue layer did you place the mesh? (onlay, retromuscular, extra peritoneal or intraabdominal) no information. If applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) no information. How was the event diagnosed? no information. What is the patients current status? fine. Date and results of reoperation. No date information and results were fine. Are any photos available? no information. Search Alerts/Recalls22 New Search | Submit an Adverse Event Report23
Brand Name PHYSIOMESH OVAL Type of Device MESH, SURGICAL, POLYMERIC Manufacturer (Section D)ETHICON INC. P.O. Box 151, Route 22 West Somerville NJ 08876 0151 Manufacturer (Section G)ETHICON INC.GMBH RobertKoch Strasse 1 Norderstedt D228 51 GERMANY D22851 Manufacturer ContactKenneth Clark https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5758664&pc=FTL
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6/2/2017
MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH OVAL MESH, SURGICAL, POLYMERIC
Route 22 Westp O Box 151 Somerville , NJ 08876 9082183547 MDR Report Key5758664 Report Number2210968201610069 Device Sequence Number1 Product CodeFTL24 Report SourceManufacturer Source TypeCOMPANY REPRESENTATIVE,FOREIG Reporter OccupationOther Type of ReportInitial,Followup Report Date06/13/2016 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received06/29/2016 Is This An Adverse Event Report?Yes Is This A Product Problem Report?No Device OperatorHealth Professional Device EXPIRATION Date02/28/2017 Device Catalogue NumberPHY2025V Device LOT NumberJC8BDWB0 Was Device Available For Evaluation?Yes Is The Reporter A Health Professional?No Was the Report Sent to FDA?No Event LocationNo Information Date Manufacturer Received07/11/2016 Was Device Evaluated By Manufacturer?No Date Device Manufactured03/01/2015 Is The Device Single Use?Yes Is this a Reprocessed and Reused SingleUse Device?No Type of Device UsageInitial Patient TREATMENT DATA Date Received: 06/29/2016 Patient Sequence Number: 1 Treatment POLYSORB
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5758664&pc=FTL
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