MAUDE Adverse Event Report: COOK BIOTECH, INC. BIODESIGN SURGISIS MESH; MESH, SURGICAL

Catalog Number 636032

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

Patient called the office to report she had seen a plastic surgeon and was told the mesh inserted (b)(6) 2019 was "balled up on the left side".Fda safety report id # (b)(4).

• Brand Name: BIODESIGN SURGISIS MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): COOK BIOTECH, INC.
• MDR Report Key: 13618903
• MDR Text Key: 286358975
• Report Number: MW5107744
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2019
• Device Catalogue Number: 636032
• Device Lot Number: LB1127698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White