MAUDE Adverse Event Report: ETHICON INC. PROCEED VENTRAL PATCH::SIZE 6.4 X 6.4 CM; MESH, SURGICAL, POLYMERIC

Catalog Number XCPVPM

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

Patient Problems Fatigue (1849); Pain (1994)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in 2020.It was reported that the patient had a proceed hernia mesh installed and for the past 4 years suffered with debilitating, chronic abdominal pain and extreme fatigue.It was reported that the patient had been to 4 different doctors for evaluation.It was also reported that for the past 6 months, the patient had been in limbo; due partly to covid.It was reported that the surgeon the patient spoke with last ordered a ct scan and after reviewing the results, expressed a concern for having to dig out the existing mesh.It was also reported that he suggested the patient hold off until it becomes life-threatening.It was reported that the patient has to deal with this pain every day.It was reported that the patient's exercise is severely limited because so many exercise motions cause more pain and discomfort.

Manufacturer Narrative

Product complaint (b)(4).Date sent to the fda: 07/02/2020.Corrected information: d4, g1, g5.Additional information: a2, b7, d1, d4, d6, d10, h4.Additional b5 narrative: it was reported that a patient underwent a reduction and repair of an incarcerated umbilical hernia on (b)(6) 2010 and the proceed ventral mesh was implanted.It was reported that for the past 4 years the patient suffered with debilitating, chronic abdominal pain and extreme fatigue.It was also reported that for the past 6 months, the patient had been in limbo; due partly to covid.It was reported that the surgeon the patient spoke with last ordered a ct scan and after reviewing the results, expressed a concern for having to ¿dig out¿ the existing mesh.It was also reported that he suggested the patient hold off until it becomes life-threatening.It was reported that the patient has to deal with this pain every day.It was also reported that the patient's exercise is severely limited because so many exercise motions cause more pain and discomfort.

Manufacturer Narrative

Date sent to fda:07/10/2020.Additional information: e1, e2, e4, g3.Corrected information: d6.Corrected b5 narrative: it was reported that the patient underwent hernia repair surgery on (b)(6) 2010 and mesh was implanted.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROCEED VENTRAL PATCH::SIZE 6.4 X 6.4 CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10156188
• MDR Text Key: 196203972
• Report Number: 2210968-2020-04582
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2011
• Device Catalogue Number: XCPVPM
• Device Lot Number: CB8LBSZ0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Patient Sequence Number: 1
• Treatment: 0 PROLENE SUTURE; 3-0 VICRYL SUTURE
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR