MAUDE Adverse Event Report: BARD SHANNON LIMITED BARD SOFT MESH; MESH, SURGICAL, POLYMERIC

Model Number 0117016

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

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930)

Event Date 01/15/2019

Event Type  Injury  

Event Description

Had 2nd surgery; my stomach busted open in february and i got a bad infection which required nursing care, wound vac and another surgery and i lost my belly button.Have a lot of belly pain and setonas and have had multiple tests and a couple different doctors.I have had ultrasound of abdomen and ct scans that have showed it.Fda safety report id# (b)(4).

• Brand Name: BARD SOFT MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD SHANNON LIMITED
• MDR Report Key: 11108042
• MDR Text Key: 225090874
• Report Number: MW5098622
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/26/2023
• Device Model Number: 0117016
• Device Catalogue Number: 0117016
• Device Lot Number: HUCW1436
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 57 YR
• Patient Weight: 82