BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGADERM CHG DRESSING

    MDR report key: 1942578 · Received December 23, 2010

    Report

    Report Number
    2110898-2010-00155
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 24, 2010
    Manufacturer
    3M HEALTH CARE
    Product Code
    FRO
    PMA / PMN Number
    K080620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: DEVICE NOT RETURNED, NO EVAL WILL BE PERFORMED. DEVICE OR LOT CODE NOT PROVIDED TO MFR FOR EVAL. COMPLAINT TYPE WILL BE MONITORED. THE INSERT PROVIDES THE FOLLOWING INFO REGARDING OBSERVATION AND WHEN A DRESSING SHOULD BE CHANGED. SITE CARE: THE SITE SHOULD BE OBSERVED DAILY FOR SIGNS OF INFECTION OR OTHER COMPLICATIONS. IF INFECTION IS SUSPECTED, REMOVE THE DRESSING, INSPECT THE SITE DIRECTLY, AND DETERMINE APPROPRIATE MEDICAL INTERVENTION. INFECTION MAY BE SIGNALED BY FEVER, PAIN, REDNESS, SWELLING, OR UNUSUAL ODOR OR DISCHARGE. CHANGE THE DRESSING AS NECESSARY, IN ACCORDANCE WITH FACILITY PROTOCOL; DRESSING CHANGES SHOULD OCCUR AT LEAST EVERY 7 DAYS, PER CURRENT CDC RECOMMENDATIONS. DRESSING CHANGES MAY BE NEEDED MORE FREQUENTLY WITH HIGHLY EXUDATIVE SITES OR IF INTEGRITY OF THE DRESSING IS COMPROMISED.

    Description of Event or Problem · 1

    PT SUFFERED A SKIN REACTION THAT APPEARED BURNED WITH A BUMPY RASH AND A BREAKDOWN OF SKIN UNDER THE TEGADERM CHG GEL PAD. PT COMPLAINED OF ITCHING. THE DRESSING WAS IN PLACE FOR MORE THAN 24 HRS BEFORE THE SYMPTOMS DEVELOPED. THE SYMPTOMS DID NOT OCCUR WITH THE FIRST USE OF THE TEGADERM CHG DRESSING. IT IS UNK THE NUMBER OF TIMES THAT A TEGADERM CHG DRESSING WAS USED. DUE TO THE SYMPTOMS, THE USE OF THE TEGADERM CHG DRESSING WAS DISCONTINUED, AS THE TYPE OF MEDICAL TREATMENT. AS A RESULT OF THIS INCIDENT, THE CATHETER WAS REMOVED. THE OUTCOME OF THE SKIN REACTION IS UNK. PT HAD NOT RETURNED TO THE CLINIC. NO FURTHER TREATMENT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEGADERM CHG DRESSING UNCLASSIFIED - DRESSING, WOUND, DRUG FRO 3M HEALTH CARE NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CATHETER| CHLORAPREP (SKIN ANTISEPSIS)| ANTIBIOTICS (THERAPY VIA PICC LINE / VAD)| PICC| APLICARE (SKIN PROTECTION)| STAT-LOCK