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

Catalog Number PHSM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Hypoesthesia (2352); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date sent to fda: 9/22/2017.(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a hernia repair surgery in (b)(6) 2007 and mesh was implanted (tacked by 4 sutures).Several months later, he felt a stabbing pain in the groin and began to develop numbness and motor skills problems.He was diagnosed with foot drop and examined at several (b)(6) hospitals over the next few years, and then told in 2015 that the pain was from the mesh.No additional information was provided.

• Brand Name: PROLENE
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 6885859
• MDR Text Key: 87203623
• Report Number: 2210968-2017-70122
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2011
• Device Catalogue Number: PHSM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• Date Device Manufactured: 08/24/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention