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

Catalog Number PHSE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Hypoesthesia (2352); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.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 by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2011 and mesh was implanted.It was reported that the patient experienced sharp pains in his groin, numbness and constant pain and was diagnosed with right-sided ilioinguinal neuropathy that required multiple procedures, including nerve block injections and laser treatments.No additional information was provided.

Manufacturer Narrative

Date sent to fda: (b)(4) 2018.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 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, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7499320
• MDR Text Key: 107753111
• Report Number: 2210968-2018-72163
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048935
• UDI-Public: 10705031048935
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

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: 07/31/2015
• Device Catalogue Number: PHSE
• Device Lot Number: 2249651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 08/29/2018
• Date Device Manufactured: 09/09/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR