MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX DEVICE; MESH, SURGICAL

Device Problems Material Disintegration (1177); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2021

Event Type  Injury  

Event Description

I was diagnosed with inguinal hernia, right side.On (b)(6) 2021 i had surgery to insert a biological mesh - gentrix surgical mesh device engineered with matristem by acell.The mesh failed completely, worsening my hernia condition, and requiring a second surgery in (b)(6) 2021.The surgeon reported the biological mesh had completely dissolved, as if it was never there before.The surgeon reported the product failure to the manufacturer and has discontinued using this device.Fda safety report id# (b)(4).

• Brand Name: GENTRIX SURGICAL MATRIX DEVICE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ACELL, INC.
• MDR Report Key: 12682166
• MDR Text Key: 278219404
• Report Number: MW5104878
• Device Sequence Number: 1
• Product Code: FTM
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Weight: 86