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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED VENTRAL PATCH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PVPM1
Device Problems Break (1069); Peeled/Delaminated (1454); Tear, Rip or Hole in Device Packaging (2385); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. It was reported that the device "broke" while being implanted. Please indicate what portion of the mesh "broke" for example was it the mesh tabs, nonabsorbable pds sutures attached to the mesh tabs or did the mesh tear during insertion?.
 
Event Description
It was reported that the patient underwent a ventral hernia repair on 10/11/2018 and the mesh was implanted. When inserting into patient, the mesh broke. There were no patient consequences reported. Another like device was used to complete the procedure. Additional information has been requested.
 
Manufacturer Narrative
Date sent to the fda: 11/28/2018. Additional information was requested, and the following was obtained: it was reported that the device "broke" while being implanted. Please indicate what portion of the mesh "broke" for example was it the mesh tabs, nonabsorbable pds sutures attached to the mesh tabs or did the mesh tear during insertion? the doctor explains that the mesh broke as she was placing the mesh into the open defect with some sponge graspers. By this she means that the tissue separating component of the mesh broke away from the prolene part of the mesh - the mesh separated into 2 pieces. Therefore, a doctor was not able to use the mesh.
 
Manufacturer Narrative
Date sent to the fda: 01/06/2019. Additional summary: an empty opened foil, opened folder and a proceed ventral patch were returned for analysis. During visual inspection of the sample, body fluids on the mesh was noted; also, the two wings were partially broken, due to the ventral patch has begun with degradation process. In the visual inspection of opened foil, showed excessive manipulation and multiples holes on the wrinkles consistent with excessive manipulation. The seal area was examined visually, and it was noted to be complete and no damaged or wrinkles were present. Per the foil condition the assignable cause of the performance - loss of integrity - intra op was a result of pin holes in the foil consistent with excessive manipulation resulting in a degradation of the mesh ventral patch.
 
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Brand NamePROCEED VENTRAL PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8044660
MDR Text Key126510045
Report Number2210968-2018-76996
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K061533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Catalogue NumberPVPM1
Device Lot NumberMA8BSRB0
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device?

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