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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON / ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number DONT KNOW
Device Problem Defective Component (2292)
Patient Problems Unspecified Infection (1930); Pain (1994); Perforation (2001); Complaint, Ill-Defined (2331)
Event Date 06/04/2019
Event Type  Injury  
Event Description

Back in (b)(6) 2010 i had a prolene mesh placed for a hernia surgery. All of a sudden on (b)(6) 2019 i had severe pain, infection, perforation, life threatening complications, mesh had failed, rush to hosp, had to have two add'l surgeries, blood transfusion, bowel and urinary issues, icu stay, in hosp for a month had to have another mesh placed and many more things done. Retained a lawyer but they say my mesh hasn't been recalled like the others. Terrible unbelievable. This was all due to failed mesh. It is from same years as all other recalled meshes and by same mfr johnson & johnson. Please recall this mesh product so justice can be served. "two surgeries, and" please recall immediately. Fda safety report id# (b)(4).

 
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Brand NamePROLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON / ETHICON, INC.
MDR Report Key8784895
MDR Text Key150968787
Report NumberMW5088029
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 07/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/11/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date06/04/2019
Device MODEL NumberDONT KNOW
Device Catalogue NumberDONT KNOW
Device LOT NumberDONT KNOW
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: 07/11/2019 Patient Sequence Number: 1
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