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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SKIN-PREP WIPES BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
Model Number 420400
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Mother reports site is not adhering to skin very well. They have been using skin prep wipes. Author advised the skin prep wipes are used to create a barrier between skin and adhesive to help prevent irritation. Suggested they try not using skin prep wipes. No other information available. Reported to (b)(6) by pt/caregiver.
 
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Brand NameSKIN-PREP WIPES
Type of DeviceBANDAGE, LIQUID, SKIN PROTECTANT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
MDR Report Key11760666
MDR Text Key248859532
Report NumberMW5101125
Device Sequence Number1
Product Code NEC
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420400
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
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

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