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 Nerve Damage (1979); Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2019 and mesh was implanted during which the surgeon noted the mesh was appreciated and scarred in significantly and was bundled up.He was not able to appreciate a clear ilioinguinal nerve and suspected that the nerve was contained within the bundle of scar tissue and mesh that was removed.It was reported that the patient underwent inguinal herniorrhaphy on (b)(6) 2022 during which the surgeon noted significant amount of residual mesh and scarring from previous surgery so he dissected out the underlay portion of the previous mesh, opening that it may have ben the source of nerve entrapment.It was reported that the patient experienced an unknown adverse event.Other procedure is captured under separate file.No additional information was provided.

Manufacturer Narrative

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.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2019.Mwr-(b)(4) submitted for adverse event which occurred on (b)(6) 2022.

Manufacturer Narrative

Date sent to the fda: 5/12/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 08/18/2022.Additional information: a2, b7.Additional b5 narrative: it was reported that the patient experienced pain following surgery.Date sent to the fda: 08/18/2022.Corrected information: d6a.Corrected b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2019 and mesh was implanted.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14296217
• MDR Text Key: 294671394
• Report Number: 2210968-2022-03387
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048966
• UDI-Public: 10705031048966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

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: 05/31/2022
• Device Model Number: PHSL
• Device Catalogue Number: PHSL
• Device Lot Number: 31247J03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/06/2022
• Supplement Dates Manufacturer Received: 05/09/2022; 08/17/2022
• Supplement Dates FDA Received: 05/12/2022; 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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: 60 YR
• Patient Sex: Male