BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES

    MDR report key: 6967582 · Received October 21, 2017

    Report

    Report Number
    1018233-2017-05375
    Event Type
    Injury
    Date Received
    October 21, 2017
    Report Date
    November 10, 2017
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EXB
    UDI-DI
    10801741072779
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "BARD PROTECTIVE BARRIER FILM. PRESCRIPTION ONLY. LATEX FREE. CATALOG NO. 740013. HELPS PROTECT SKIN AROUND WOUNDS AND STOMAS FROM IRRITATION OF EXUDATE AND DIGESTIVE JUICES (ACTIVE ENZYMES), URINE AND IRRITATION CAUSED BY ADHESIVES. BONDS TO SKIN AND HELPS PREVENT THESE IRRITANTS FROM COMING IN CONTACT WITH SENSITIVE AREAS. ALSO FOR USE WITH EXTERNAL CATHETER TO HELP PROTECT AGAINST URINE OR ADHESIVE IRRITATION. DIRECTIONS: PREPARE ARE BY CLEANSING WITH A GENTLE SKIN CLEANSER. RINSE AND DRY THOROUGHLY. APPLY BARD PROTECTIVE BARRIER FILM WITH WIPE AND ALLOW TO DRY FOR 1 MINUTE. MOMENTARY STING WILL BE FELT WHEN APPLIED TO EXCORIATED SKIN. CONTAINS: ISOPROPANOL, BUTYL ESTER OF PVM/MA, ACETYL TRIBUTYL CITRATE." (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE OF THE DEVICE, THE PATIENT EXPERIENCED REDNESS, RAISED SKIN, SKIN TEAR, DRAINAGE, AND FOUL ODOR. THE AREA OF THE ALLEGEDLY INFECTED SKIN WAS THE SAME CIRCUMFERENCE AS THE LIBRE PRO CONTINUOUS GLUCOSE MONITOR. ALLEGEDLY, ALCOHOL WAS USED TO CLEAN THE PATIENT'S SKIN BEFORE PLACING THE PROTECTIVE BARRIER FILM ON THE SKIN. THEN, A LIBRE PRO CONTINUOUS GLUCOSE MONITOR WAS PLACED IN THE PATIENTS SKIN WITH A NEEDLE. THE PROTECTIVE BARRIER FILM WAS USED ON THE PATIENTS SKIN FOR 13 DAYS. ALLEGEDLY, THE PATIENT VISITED A NON-EMERGENT CARE FACILITY DUE TO THE EXPERIENCED REDNESS, RAISED SKIN, SKIN TEAR, DRAINAGE, AND FOUL ODOR. IT WAS LATER REPORTED, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC CALLED KEFLEX AND A TOPICAL ANTIBIOTIC. THE LOCATION OF THE ALLEGED INFECTED SKIN WAS ON THE PATIENT'S RIGHT ARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A RESULT OF THE USAGE OF OUR DEVICE, THE PATIENT EXPERIENCED REDNESS, RAISED SKIN, SKIN TEAR, DRAINAGE, AND FOUL ODOR. THE AREA OF THE ALLEGEDLY INFECTED SKIN WAS THE SAME CIRCUMFERENCE AS THE LIBRE PRO CONTINUOUS GLUCOSE MONITOR. ALLEGEDLY ALCOHOL WAS USED TO CLEAN THE PATIENT'S SKIN BEFORE PLACING THE PROTECTIVE BARRIER FILM ON THE SKIN. THEN, A LIBRE PRO CONTINUOUS GLUCOSE MONITOR WAS PLACED IN THE PATIENTS SKIN WITH A NEEDLE. THE PROTECTIVE BARRIER FILM WAS USED ON THE PATIENTS SKIN FOR 13 DAYS. ALLEGEDLY, THE PATIENT VISITED A NON-EMERGENT CARE FACILITY DUE TO THE EXPERIENCED REDNESS, RAISED SKIN, SKIN TEAR, DRAINAGE, AND FOUL ODOR. IT WAS LATER REPORTED, THE PATIENT WAS PRESCRIBED AN ANTIBIOTIC CALLED KEFLEX AND A TOPICAL ANTIBIOTIC. THE LOCATION OF THE ALLEGED INFECTED SKIN WAS ON THE PATIENT'S RIGHT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747032 BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES PROTECTIVE BARRIER FILM WIPES EXB C.R. BARD, INC. (COVINGTON) -1018233 UNK 10801741072779

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention