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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Material Separation (1562)
Patient Problems Hernia (2240); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.

 
Event Description

It was reported that the patient underwent an unknown procedure in 2009 and mesh was implanted. The patient reported that the product began degrading and he required additional surgery. The original mesh was unable to be removed and new mesh was placed over the same area. The patient noted that he has been back to the emergency room five times since (b)(6) 2017. Additional information will be requested.

 
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Brand NamePROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6727590
MDR Text Key80513121
Report Number2210968-2017-33029
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK962530
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 06/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/20/2017 Patient Sequence Number: 1
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