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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DERMARITE INDUSTRIES, LLC. XEROFORM GAUZE DRESSING WITH 3% BISMUTH TRIBROMOPHENATE; DRESSING, WOUND, DRUG
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DERMARITE INDUSTRIES, LLC. XEROFORM GAUZE DRESSING WITH 3% BISMUTH TRIBROMOPHENATE; DRESSING, WOUND, DRUG Back to Search Results
Model Number 24220
Health Effect - Clinical Codes Inflammation (1932); Pain (1994); Deformity/ Disfigurement (2360); Partial thickness (Second Degree) Burn (2694); Blister (4537)
Date of Event 08/23/2021
Type of Reportable Event Serious Injury
Event or Problem Description
Severe pain, skin blistering, inflammation, burning and disfiguring of skin and effect of antibiotic i was on.An incorrect device was sent home from halo wound solutions, my doctor ordered an adaptic and script correctly and packaged the wrong adaptor.This device was to help with a wound on my ankle.I notified halo, my doctor and my pharmacist of the severe and painful reactions i was experiencing.It provides all the informed you need.I am also including photos of the injuries suffered and ongoing.Please note there was no warning on the single packets that this product can burn the skin.I found out afterwards through intense research on the internet.
 
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Brand Name
XEROFORM GAUZE DRESSING WITH 3% BISMUTH TRIBROMOPHENATE
Common Device Name
DRESSING, WOUND, DRUG
Manufacturer (Section D)
DERMARITE INDUSTRIES, LLC.
MDR Report Key12598286
Report NumberMW5104474
Device Sequence Number1447108
Product Code FRO
Initial Reporter StateNJ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 09/25/2021
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? No
Operator of Device No Information
Device Expiration Date01/06/2026
Device Model Number24220
Device Lot NumberF-20210602
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/07/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age68 YR
Patient Weight58
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