MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Catalog Number PHSL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Pain (1994); Scarring (2061); Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

(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.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.

Event Description

It was reported by an attorney that the patient underwent left ventral hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient underwent incisional hernia repair surgery on (b)(6) 2010 during which the surgeon noted a portion of the previously placed mesh was in the wound and was to be trimmed away.It was reported that the patient experienced severe pain, numbness, disfigurement, scarring, inflammation, stress and anxiety.No additional information was provided.

Manufacturer Narrative

Additional narrative: it was reported that following an insertion the patient experienced abdominal pain.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8604977
• MDR Text Key: 144863103
• Report Number: 2210968-2019-80812
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048966
• UDI-Public: 10705031048966
• 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,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2011
• Device Catalogue Number: PHSL
• Device Lot Number: 15964-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention