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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
Lot Number CGBMGQZ0
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 07/04/2021
Event Type  Injury  
Event Description
Pt states that on (b)(6) 2021, he experienced sudden onset abdominal pain and was seen in the er. Pt reports that the pain worsened over the 6 hours that he was waiting in the hospital and pain medication did not resolve his symptoms. Pt states that he had a ct done but that it was only a partial read due to his curled up body positioning from the pain. Pt states after review of the ct he was taken into emergency surgery for mesh failure and abdominal region collapse. Pt reports that during his surgery both the failed mesh in his umbilical and inguinal region were removed and replaced. Pt notes that since the removal of the failed mesh, he no longer feels any symptoms but notes residual tightness when he stretches which he attributes to be adjustment from new surgery.
 
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Brand NamePROCEED VENTRAL PATCH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON, INC.
MDR Report Key13258086
MDR Text Key284012585
Report NumberMW5106676
Device Sequence Number2
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/13/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Lot NumberCGBMGQZ0
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/13/2022 Patient Sequence Number: 1
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