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

Model Number PHSM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Hematoma (1884); Nerve Damage (1979); Seroma (2069); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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) 2011 and mesh was implanted.It was reported that the patient underwent removal surgery and inguinal hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted the mesh was found to be wrapped completely around the cord structures.The inguinal canal floor was disrupted.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

Date sent to the fda: 03/22/2021.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: 09/29/2021.H6 health effect - clinical code: e2402 used to capture mesh migration.It was reported that the patient experienced hernia recurrence, adhesions, mesh migration, abdominal pain, nerve damage, seroma and hematoma following surgery.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11437319
• MDR Text Key: 238875645
• Report Number: 2210968-2021-02097
• 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: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: PHSM
• Device Catalogue Number: PHSM
• Device Lot Number: 23625-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR