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

Lot Number CGBMGQZ0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 07/04/2021

Event Type  Injury  

Event Description

Pt states that on (b)(6) 2021, he experienced sudden onset abdominal pain and was seen in the er.Pt reports that the pain worsened over the 6 hours that he was waiting in the hospital and pain medication did not resolve his symptoms.Pt states that he had a ct done but that it was only a partial read due to his curled up body positioning from the pain.Pt states after review of the ct he was taken into emergency surgery for mesh failure and abdominal region collapse.Pt reports that during his surgery both the failed mesh in his umbilical and inguinal region were removed and replaced.Pt notes that since the removal of the failed mesh, he no longer feels any symptoms but notes residual tightness when he stretches which he attributes to be adjustment from new surgery.

Event Description

Additional information received on 13-mar-2023 from reporter for mw5106676.Reporter calling to correct info.

Event Description

Additional information received on 13-mar-2023 from reporter for mw5106676.Reporter calling to add information.

• Brand Name: PROCEED VENTRAL PATCH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON, INC.
• MDR Report Key: 13258086
• MDR Text Key: 284012585
• Report Number: MW5106676
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: CGBMGQZ0
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male