MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM; MESH, SURGICAL, POLYMERIC

Model Number PVPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Cramp(s) (2193); Hernia (2240)

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 a hernia repair surgery on (b)(6) 2015 and mesh were implanted.It was reported that the patient had a mesh removal surgery on (b)(6) 2016 at (b)(6) in (b)(6).It was reported that the patient continues to experience pain, nausea, diarrhea, chills, inflammation, loss of appetite and weight loss.No additional information was provided.

Manufacturer Narrative

Date sent to fda: 6/27/2019.Corrected narrative: it was reported that the patient had a mesh removal surgery on (b)(6) 2016.

Manufacturer Narrative

Date sent to fda: 09/15/2020.Additional narrative: it was reported that the patient experienced hernia recurrence, cramping, constipation and scar tissue following surgery.

• Brand Name: PVP SMALL 4.3CM X 4.3CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7289204
• MDR Text Key: 100692645
• Report Number: 2210968-2018-70971
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132412
• UDI-Public: 10705031132412
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PVPS
• Device Catalogue Number: PVPS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR