BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-DRAPE INCISE DRAPE

    MDR report key: 4919510 · Received July 7, 2015

    Report

    Report Number
    2110898-2015-00028
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 10, 2015
    Manufacturer
    3M HEALTH CARE
    Product Code
    KKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE WAS NOT PROVIDED.: NO LOT NUMBER WAS PROVIDED AND WITHOUT A LOT NUMBER THE EXPIRATION DATE AND MANUFACTURE DATE CAN NOT BE DETERMINED. (B)(6). DEVICES PLACED ON THE MARKET BEFORE MAY 28, 1976 ARE CONSIDERED PRE-AMENDMENT DEVICES AND WERE NOT SUBJECT TO A 510 (K). FDA JUST RECENTLY EXEMPTED SURGICAL DRAPES UNDER KKX PRODUCT CODE FROM 510 (K)'S.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT A MALE PATIENT HAD A TOTAL KNEE SURGICAL PROCEDURE SOMETIME IN 2015. THE PATIENT'S KNEE WAS PREPARED WITH AN UNSPECIFIED SURGICAL SOLUTION CONTAINING 2% CHLORHEXIDINE GLUCONATE. A 3M INCISE DRAPE WAS PLACED ON PATIENT'S KNEE. THE SURGEON ALLEGED THAT THE DRAPE LIFTED DURING SURGERY. THE PATIENT DEVELOPED AN INFECTION FOLLOWING THE SURGERY. NO DETAILS WERE PROVIDED ABOUT MEDICAL TREATMENT FOR THE INFECTION NOR THE TYPE OF INFECTION. THE HOSPITAL WAS USING A NEW SURGICAL PREP AND DID NOT ALLOW IT TO DRY PRIOR TO PLACEMENT OF THE DRAPE. PRODUCT LABELING DOES STATE UNDER DIRECTIONS FOR USE: "MAKE SURE SKIN IS DRY" AND "APPLY STERI-DRAPE OR STERI-DRAPE 2 INCISE DRAPE TO THOROUGHLY DRY INTACT SKIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437737 3M STERI-DRAPE INCISE DRAPE DRAPE, SURGICAL KKX 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SURGICAL SOLUTION CONTAINING| 2% CHLORHEXIDINE GLUCONATE| NAME OF PRODUCT NOT PROVIDED.