BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M SCOTCAST WET OR DRY CAST PADDING

    MDR report key: 3800242 · Received April 30, 2014

    Report

    Report Number
    2110898-2014-00024
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    August 23, 2013
    Report Date
    March 20, 2014
    Manufacturer
    3M HEALTH CARE
    Product Code
    ITG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VOLUNTARY 2013 RECALL WAS INITIATED AFTER AND INVESTIGATION OF CUSTOMER FEEDBACK WAS CONDUCTED AND INTERNAL TESTING WAS PERFORMED, IT WAS FOUND THAT THE CAST PADDING MATERIAL DID NOT CONSISTENTLY REPEL WATER. LACK OF REPELLENCY MAY RESULT IN PROLONGED CAST DRYING TIMES AFTER EXPOSURE TO WET CONDITIONS. FDA ASSIGNED RECALL NUMBER WAS: Z-2242-2013.

    Description of Event or Problem · 1

    HOLD - AB 05/09/2014 IT WAS REPORTED THAT A (B)(6) MALE SUFFERED SKIN MACERATION UNDER THE CASTING MATERIALS USED AT A USER FACILITY. THE PATIENT'S FATHER STATED THAT HE ALLOWED HIS SON TO SWIM IN A POOL AND BATHE, BUT NEVER ALLOWED HIM TO SWIM OR PLAY IN ANY LAKES, RIVERS OR OCEANS. THE FATHER REPORTED THAT THERE WAS SIGNIFICANT EXCORIATION OF THE SKIN WITH A RASH INVOLVING THE ENTIRE AREA UNDERNEATH THE CAST WITH SOME PEELING OF THE SKIN THAT WAS PROMINENT. PATIENT'S PARENTS WERE ADVISED TO PROCEED WITH LOCAL WOUND CARE AND FOLLOW-UP TREATMENT. PARENTS SCHEDULED FOLLOWED-UP TREATMENT WITH FAMILY DOCTOR (3 VISITS) FOR WOUND CARE. THE DOCTOR GAVE THE PATIENT A SHOT AS A PRECAUTIONARY MEASURE FOR INFECTION AND ADVISED THE PARENTS TO APPLY TOPICAL ANTIBIOTIC CREAM AND DRESSING TO THEIR SON'S ARM TWICE A DAY UNTIL THE SKIN RECOVERED. THE PATIENTS FATHER STATED THAT THIS WENT ON FOR APPROXIMATELY 3 MONTHS, BUT PATIENT IS DOING WELL NOW. THE INITIAL REPORT WAS SENT TO THE COMPANY ON (B)(4) 2014 BY THE USER FACILITY AS THE BILL FOR SERVICES WENT INTO COLLECTIONS. NO SAMPLE AND NO LOT NUMBER WERE PROVIDED. THE FACILITY CONTACT THAT REPORTED THE COMPLAINT TO COMPANY REPRESENTATIVE DID NOT RESPOND TO ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED INCIDENT. A CERTIFIED LETTER HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258262 3M SCOTCAST WET OR DRY CAST PADDING BANDAGE, CAST ITG 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other