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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON / ETHICON, INC. ULTRAPRO HERNIA MESH SYSTEM MESH, SURGICAL, POLYMERIC

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JOHNSON & JOHNSON / ETHICON, INC. ULTRAPRO HERNIA MESH SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Perforation (2205)
Patient Problems Adhesion(s) (1695); No Code Available (3191)
Event Date 11/22/2019
Event Type  Injury  
Event Description

Had ethicon ultrapro hernia mesh system implanted in 2015. In 2019, while having prostate surgery, small intestine adhesion to mesh also had a perforation. Had 4 inches of the affected intestine removed. Pathology report indicated mesh granules in the sample. Fda safety report id# (b)(4).

 
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Brand NameULTRAPRO HERNIA MESH SYSTEM
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
JOHNSON & JOHNSON / ETHICON, INC.
MDR Report Key9805171
MDR Text Key182893450
Report NumberMW5093608
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 03/05/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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: 03/06/2020 Patient Sequence Number: 1
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