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

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

Patient Problems Pulmonary Embolism (1498); Abscess (1690); Fever (1858); Sepsis (2067); Seroma (2069)

Event Date 01/09/2019

Event Type  Injury  

Event Description

A-cell biological mesh was implanted during an abdominal hernia repair at (b)(6) hosp.I immediately experienced adverse rejection effects, including fever and pulmonary embolisms.I developed sepsis, new hernias, seromas and abscesses.The mesh formed a ball, my body formed a thick capsule around it.This "mesh ball" was removed at (b)(6) hospital in (b)(6) 2019 and i was on a wound vac until (b)(6) 2019.The remaining mesh continued to cause problems with abscesses and fevers.I had another removal surgery (b)(6) 2019.Despite mesh removal, i developed an abscess in (b)(6) 2020.I believe this mesh is faulty and should be removed from the market.Fda safety report id # (b)(4).

• Brand Name: ACELL MESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): ACELL, INC.
• MDR Report Key: 9805319
• MDR Text Key: 182922850
• Report Number: MW5093617
• 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: Patient
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 53 YR
• Patient Weight: 82