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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DYNAREX DYNAREX UNNA BOOT BANDAGE

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DYNAREX DYNAREX UNNA BOOT BANDAGE Back to Search Results
Lot Number 63370
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 02/15/2017
Event Type  malfunction  
Event Description
Open box of dynarex flexible unna boot bandage with calamine and found mold on the product lot number is: 63370 expiration date: 03/2021, mfr: (b)(4). Opened to use on a pt but saw mold so was not used. You may contact me at: (b)(6). Route: topical. Diagnosis or reason for use: lymphedema. Is the product over-the-counter: yes.
 
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Brand NameDYNAREX UNNA BOOT BANDAGE
Type of DeviceDYNAREX UNNA BOOT BANDAGE
Manufacturer (Section D)
DYNAREX
MDR Report Key6345530
MDR Text Key67950222
Report NumberMW5067965
Device Sequence Number1
Product Code NEC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2021
Device Lot Number63370
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 02/16/2017 Patient Sequence Number: 1
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