• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALLODERM SELECT DUO ACCELLULAR DERMALMATRIX MESH, SURGICAL Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLODERM SELECT DUO ACCELLULAR DERMALMATRIX
Type of DeviceMESH, SURGICAL
MDR Report Key12894304
MDR Text Key281543970
Report NumberMW5105673
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number1519320P
Device Lot NumberRH227629-012
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/29/2021 Patient Sequence Number: 1
Treatment
ATIVAN .25MG ; BACLOFEN 10MG ; FOLIC ACID ; IBUPROFEN 600MG ; LYRICA
-
-