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

Model Number PHSL

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

Patient Problems Inflammation (1932); Ischemia (1942); Pain (1994)

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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2009 during which the surgeon noted a piece of mesh densely adhered to the spermatic cord and the surrounding tissue and despite the mesh was cut adequately to accommodate the cord, attempt to further dissect the cord from the dense inflammatory tissue incited by the mesh could risk causing testicular ischemia.It was reported that the patient experienced chronic groin pain and pubic pain.No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 08/24/2021.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10528272
• MDR Text Key: 206762829
• Report Number: 2210968-2020-06818
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048966
• UDI-Public: 10705031048966
• Combination Product (y/n): N
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHSL
• Device Catalogue Number: PHSL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention