MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. XENMATRIX AB SURGICAL GRAFT; MESH, SURGICAL

Model Number 1151520

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2021

Event Type  Injury  

Event Description

Failure of the mesh used during an abdominal repair.Fda safety report id# (b)(4).

• Brand Name: XENMATRIX AB SURGICAL GRAFT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.
• MDR Report Key: 12365824
• MDR Text Key: 268314173
• Report Number: MW5103490
• Device Sequence Number: 1
• Product Code: FTM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1151520
• Device Catalogue Number: 1151520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention