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

Catalog Number PHSL

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Pain (1994); Treatment with medication(s) (2571)

Event Type  Injury  

Manufacturer Narrative

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

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

• Brand Name: PROLENE HERNIA SYSTEM
• Type of Device: PROLENE 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 Key: 2558746
• MDR Text Key: 16517231
• Report Number: 2210968-2012-01316
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 05/03/2012
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: PHSL
• Device Lot Number: 15894-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/09/2012
• 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