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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE CURAD XEROFORM STERILE PETROLATUM
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MEDLINE CURAD XEROFORM STERILE PETROLATUM Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Inflammation (1932); Irritation (1941); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)
Date of Event 06/15/2017
Type of Reportable Event Serious Injury
Event or Problem Description
A 3% bismuth tribromophenol was in the curad product/gauze strip that was applied to an already healing road rash/scrape of the right knee-shin that was about 5 days old and in less than an hour, itching started all over the body along with the burning feeling of the area that was covered and wrapped.Applied ice, but the burning and itching did not stop and opted to remove the wrapping and strips to notice that the skin was irritated and inflamed as if it was burned.The skin boiled as a result as it was an actual burn and that was after the application of the curad strips containing the 3% bismuth tribromophenate.I later read that people allergic to penicillin should not use the product.This should be known by all physicians.Road rash/healing flesh wound from a fall 5 days prior.Other serious/important medical incident: flesh peeling.Dates of use: (b)(6) 2017."how was it taken or used: transdermal; did the problem stop after the person reduced the dose or stopped taking or using the product: yes.".
 
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Brand Name
CURAD XEROFORM STERILE PETROLATUM
Common Device Name
CURAD XEROFORM STERILE PETROLATUM
Manufacturer (Section D)
MEDLINE
MDR Report Key6659988
Report NumberMW5070567
Device Sequence Number16552774
Product Code FRO
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 06/19/2017
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
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/19/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age34 YR
Patient Weight81
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