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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH&NEPHEW INC. SKIN PREP PROTECTIVE WIPE BANDAGE, LIQUID, SKIN PROTECTANT

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SMITH&NEPHEW INC. SKIN PREP PROTECTIVE WIPE BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
Lot Number 75520
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 NameSKIN PREP PROTECTIVE WIPE
Type of DeviceBANDAGE, LIQUID, SKIN PROTECTANT
Manufacturer (Section D)
SMITH&NEPHEW INC.
MDR Report Key10355978
MDR Text Key201688020
Report NumberMW5095847
Device Sequence Number1
Product Code NEC
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
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number75520
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/31/2020 Patient Sequence Number: 1
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