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 Adhesion(s) (1695); Foreign Body Reaction (1868); Pain (1994); Scar Tissue (2060); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

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.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.(b)(4) submitted for adverse event which occurred on (b)(6) 2008.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2004 and mesh was implanted.It was reported that the patient underwent partial removal surgery and recurrent hernia repair surgery on (b)(6) 2008.It was reported that the patient underwent removal surgery on (b)(6) 2008 during which the surgeon noted chronic drainage secondary to reaction to the old mesh.The mesh had migrated from the original implant field.Hence, he took down omental adhesions and completely removed the old mesh.It was reported that the patient experienced an unknown event.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 8/15/2021.Additional b5 narrative: it was reported that the patient experienced recurrent umbilical ventral hernia, chronic pain and scarring 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: 11305428
• MDR Text Key: 233967604
• Report Number: 2210968-2021-01231
• 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
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHSM
• Device Catalogue Number: PHSM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR