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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC

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JOHNSON AND JOHNSON / ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Disintegration (1177)
Patient Problems Unspecified Infection (1930); Pain (1994); Perforation (2001); Obstruction/Occlusion (2422)
Event Date 06/04/2019
Event Type  Injury  
Event Description

Had mesh placed after hernia surgery in (b)(6) 2010. All of a sudden on (b)(6) 2019 woke up in severe pain, infection, mesh faulty disintegrated, perforation, bowel and bladder obstruction, so rushed to hospital. Had to undergo emergency surgery for faulty mesh. Had to have two surgeries and other. Had to have two surgeries, blood transfusions, icu stay, month in hospital, foley catheter, pick line; all due to faulty mesh.

 
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Brand NamePROLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON AND JOHNSON / ETHICON, INC.
MDR Report Key8826571
MDR Text Key152457874
Report NumberMW5088371
Device Sequence Number1
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 07/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/24/2019 Patient Sequence Number: 1
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