MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Model Number PVPM

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240)

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.Mwr-(b)(4) submitted for the adverse event which occurred on (b)(6) 2019.Mwr-(b)(4) submitted for the adverse event which occurred on (b)(6) 2020.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2019 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted ¿he encountered 20 ml of purulent drainage, which was expressed.There was a loculation of necrotic tissue that was excised along with the hernia sac.There was a tight ball of previous mesh protruding through the fascia.¿ it was reported that the patient experienced severe pain, mesh erosion, nausea, infection, inflammation, weakness, stress and anxiety.The other procedure is captured in a separate file.No additional information was provided.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13110335
• MDR Text Key: 288185419
• Report Number: 2210968-2021-13048
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVPM
• Device Catalogue Number: PVPM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female