MAUDE Adverse Event Report: ALLODERM SELECT DUO ACCELLULAR DERMALMATRIX; MESH, SURGICAL

Model Number 1519320P

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Neuropathy (1983); Pain (1994); Deformity/ Disfigurement (2360)

Event Date 07/06/2021

Event Type  Injury  

Event Description

Complex open ventral hernia surgery w/ mesh implants performed on (b)(6) 2021.On (b)(6) 2021 the complications started from infection at the surgical site, neuropathy in right leg, chronic pain, deformed abdomen.Had 5 more surgeries after initial surgery to correct issues.My complications are ongoing and i'm still trying to heal a large open abdominal wound.Fda safety report id# (b)(4).

• Brand Name: ALLODERM SELECT DUO ACCELLULAR DERMALMATRIX
• Type of Device: MESH, SURGICAL
• MDR Report Key: 12894304
• MDR Text Key: 281543970
• Report Number: MW5105673
• 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: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2022
• Device Model Number: 1519320P
• Device Lot Number: RH227629-012
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATIVAN .25MG ; BACLOFEN 10MG ; FOLIC ACID ; IBUPROFEN 600MG ; LYRICA
• Patient Outcome(s): Other; Disability; Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White