BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACE COLD COMPRESS, REUSABLE

    MDR report key: 2094527 · Received April 8, 2011

    Report

    Report Number
    9710505-2011-00003
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    September 4, 2010
    Report Date
    March 31, 2011
    Manufacturer
    RAPID-AID CORP.
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFO PROVIDED, IT IS DIFFICULT TO ASCERTAIN HOW THE PRODUCT WAS USED/STORED IN BETWEEN USES. SAMPLES WAS RECEIVED AND REVIEWED (BY THE DISTRIBUTOR). LOT INFO WAS NOT ON PACKAGE AND APPEARED TO BE RUBBED OFF. THERE APPEARED TO BE A SMALL CHANNEL IN THE SEAL AREA, WHICH WAS THE PROBABLE CAUSE OF THE LEAKAGE. IT IS NOT CLEAR HOW THE PRODUCT WAS STORED/USED PRIOR TO ISSUE. TEAM WILL CONTINUE TO MONITOR FOR ANY FUTURE COMPLAINTS RELATED TO THIS ISSUE. WE HAVE NOT BEEN ABLE TO GATHER ADD'L INFO. THIS IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATED ITEM WAS PURCHASED A LITTLE OVER 1 YEAR. SHE STATED ABOUT 1 MONTH AGO ((B)(6) 2010), THE PRODUCT BURST AND GOT ON HER SKIN, ON HER RIGHT LEG. SHE STATED AREA WAS A STRAWBERRY COLOR. SHE WASHED AREA WITH SOAP. THERE WAS NO MEDICATION APPLIED TO AREA. CUSTOMER STATED AREA WAS 4 X 2 INCHES. NOW AREA HAS TURNED A BROWNISH COLOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACE COLD COMPRESS, REUSABLE REUSABLE COLD COMPRESS IME RAPID-AID CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1