MAUDE Adverse Event Report: BARD / DAVOL INC., SUB. C. R. BARD, INC. BARD MESH; MESH, SURGICAL, POLYMERIC

Catalog Number 0112660

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Chronic mesh infection, chronic open wound from 10" x 14" bard mesh.Fda safety report id# (b)(4).

• Brand Name: BARD MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): BARD / DAVOL INC., SUB. C. R. BARD, INC.
• MDR Report Key: 10401042
• MDR Text Key: 202895366
• Report Number: MW5096057
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: 0112660
• Device Lot Number: HUBQ2586
• 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): Other; Disability
• Patient Age: 55 YR