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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE HERNIA SYSTEM MESH MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE HERNIA SYSTEM MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Date sent to fda: 11/29/2016. 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 by the patient that she underwent repair of abdominal incisional hernia on (b)(6) 2002 and mesh was implanted. On (b)(6) 2010, the patient had a surgical repair of a chronically incarcerated incisional hernia. The mesh had completely detached from the fascia and several loops of bowel were within the hernia that had densely adhered to the mesh. After lysis of the adhesions, the small bowel was freed and the existing mesh was resected. A new mesh was placed over the hernia defect. The patient reported pain in the left lower quadrant post operatively. No additional information was provided.

 
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Brand NamePROLENE HERNIA SYSTEM MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
J-PAC
25 centre rd
somersworth NH 03878
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6132782
MDR Text Key61055111
Report Number2210968-2016-15177
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 11/08/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/29/2016
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 Received11/08/2016
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: 11/29/2016 Patient Sequence Number: 1
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