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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM
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ETHICON, INC. PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM Back to Search Results
Catalog Number PHSL
Event Type  Injury  
Manufacturer Narrative

(b)(4) - pain occurred. Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

 
Event Description

It was reported that a patient underwent a left groin hernia repair procedure on (b)(6) 2007 and mesh was used. Approximately (b)(6) weeks after the initial procedure, the patient experienced pain. The patient underwent a mri to determine the cause of the pain. The patient reports that the mesh has shrunk and the nerves in the groin have been affected by the mesh. The patient has had injections to relieve the pain and is currently taking ibuprofen.

 
Manufacturer Narrative

(b)(4). In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

 
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Brand NamePROLENE HERNIA SYSTEM
Type of DevicePROLENE MESH HERNIA SYSTEM
Manufacturer (Section D)
ETHICON, INC.
route 22 west
po box 151
somerville NJ 08876
Manufacturer (Section G)
J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
daniel lamont
route 22 west
po box 151
somerville , NJ 08876
9082182708
MDR Report Key2558746
Report Number2210968-2012-01316
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Patient
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/09/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberPHSL
Device LOT Number15894-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/09/2012
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: 05/03/2012 Patient Sequence Number: 1
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