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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNI-SOLVE ADHESIVE REMOVER WIPES; SOLVENT, ADHESIVE TAPE

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SMITH & NEPHEW, INC. UNI-SOLVE ADHESIVE REMOVER WIPES; SOLVENT, ADHESIVE TAPE Back to Search Results
Lot Number 7720
Device Problem Product Quality Problem (1506)
Patient Problems Rash (2033); Reaction (2414); Caustic/Chemical Burns (2549)
Event Date 07/08/2020
Event Type  No Answer Provided  
Event Description
Severe rash/chemical burn.Have a poweline catheter implant in my chest that requires dressings.I have adhesive allergies that were previously managed by using skin prep.The supply company sent smith&nephew brand adhesive remover and smith&nephew brand skin prep.However, the skin prep is in orange and green packaging while the adhesive remover is orange and dark orange.This resulted in us mixing up the two and using adhesive remover without using skin prep, resulting in a severe allergic reaction that blistered and was essentially a chemical burn.Used to prevent skin allergy reactions with dressings.Intended remove residual adhesive, but was mistaken for skin.
 
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Brand Name
UNI-SOLVE ADHESIVE REMOVER WIPES
Type of Device
SOLVENT, ADHESIVE TAPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key10355978
MDR Text Key201688020
Report NumberMW5095847
Device Sequence Number2
Product Code KOX
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/30/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number7720
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/31/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25 YR
Patient Weight99
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