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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC SUREPREP RAPID DRY NO-STING PROTECTIVE BARRIER WIPE BANDAGE, LIQUID, SKIN PROTECTANT

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MEDLINE INDUSTRIES, INC SUREPREP RAPID DRY NO-STING PROTECTIVE BARRIER WIPE BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
Catalog Number MSC1505
Device Problems Device Emits Odor (1425); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2020
Event Type  malfunction  
Event Description
Reported by nursing an issue with a box of sureprep no-sting skin protective barrier wipes. They are dried out and stuck to the inside of the package wrapper and unable to be removed. They also have a bit of an unfamiliar smell. They do not appear to have been damaged or opened. Several packages in the box of 50 wipes have been opened and are all in the same condition.
 
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Brand NameSUREPREP RAPID DRY NO-STING PROTECTIVE BARRIER WIPE
Type of DeviceBANDAGE, LIQUID, SKIN PROTECTANT
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC
three lakes drive
northfield IL 60093
MDR Report Key10013301
MDR Text Key189454544
Report Number10013301
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2020
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMSC1505
Device Lot Number45687
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2020
Event Location Hospital
Date Report to Manufacturer04/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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