MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number PHSM

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

Patient Problems Scar Tissue (2060); Hernia (2240); 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 information derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4) represents the adverse event which occurred on (b)(6) 2017.(b)(4) represents the adverse event which occurred on (b)(6) 2018.(b)(4) represents the adverse event which occurred on (b)(6) 2018.(b)(4) represents the adverse event which occurred on (b)(6) 2019.(b)(4) represents the adverse event which occurred on (b)(6) 2019.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that the patient underwent recurrent right inguinal hernia repair surgery on (b)(6) 2017 during which the surgeon noted ¿a firmed up round ball of mesh that had migrated along with scar tissue on the mesh.¿ it was reported that the patient underwent surgery for a right groin abscess on (b)(6) 2018 during which the surgeon noted ¿he incised and drained the right groin abscess and applied a wound vac.It was reported that the patient underwent removal surgery and recurrent hernia repair surgery on (b)(6) 2018 during which the surgeon noted ¿lysed adhesions down to the mesh, which was chronically infected.¿ it was reported that the patient underwent surgery to release the small bowel obstruction and resected the ischemic section of small bowel on (b)(6) 2019.It was reported that the patient underwent surgery to irrigate the area around the mesh, release the small bowel obstruction and repair recurrent hernia on (b)(6) 2019.It was reported that the patient experienced an unknown adverse event.No additional information is provided.

Manufacturer Narrative

Date sent to fda: 9/22/2020.Additional information: d4, h4.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: (b)(6) 2021.Additional information: a2, b7.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10554518
• MDR Text Key: 208385042
• Report Number: 2210968-2020-06988
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: 10705031048997
• 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,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: PHSM
• Device Catalogue Number: PHSM
• Device Lot Number: 21075-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR