BEUDAMED
    FDA Adverse Event Other Summary report: N

    COLLODIAN

    MDR report key: 2519756 · Received March 31, 2012

    Report

    Report Number
    1064095-2012-00001
    Event Type
    Other
    Date Received
    March 31, 2012
    Date of Event
    November 29, 2011
    Report Date
    March 30, 2012
    Manufacturer
    MAVIDON MEDICAL PRODUCTS
    Product Code
    IAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CONTACTED THE INITIAL REPORTER AND SHE WOULD NOT GIVE US ANY FURTHER INFORMATION INCLUDING LOT NUMBERS, AN UPDATE ON THE PATIENT CONDITIONS ETC... IN GENERAL, USING ANY TYPE OF ADHESIVE, LIKE THE COLLODION OR TAPES, ON THE SKIN FOR A LONG PERIOD OF TIME WILL RESULT IN SUFFOCATION OF THE HAIR FOLLICLES WHERE THEY WILL TEMPORARILY FALL OUT. THE MAVIDON COLODIAN WAS USED ON CONJUNCTION WITH OTHER MEDICAL DEVICES FROM OTHER COMPANIES INCLUDING ECG PADS, ECG GEL, ECG MACHINE AND THE ADHESIVE REMOVERS AT THE END OF THE PROCEDURE. THE REPORT DOES NOT MENTION IF THE ELECTRODES WERE ATTACHED FOR 8 DAYS STRAIGHT OF IF THEY REMOVED THEM PERIODICALLY. EITHER WAY, THE RISK OF TEMPORARY HAIR LOSS FOR EXTENDED MONITORING IS A KNOWN AND ACCEPTABLE RISK. IN FACT THE FACILITY HAD THE PATIENT SIGN A FORM DESCRIBING THE POTENTIAL OF THIS. WE HAVE NOT SEEN THE PICTURES DESCRIBED, BUT THE SIZE OF THE PATCHES USUALLY ARE IN DIRECT RELATION TO THE AMOUNT OF GLUE AND PASTE (WEAVER & COMPANY) USED. THE MAVIDON ADHESIVE REMOVER (COLLODION REMOVER OR MEDICAL ADHESIVE REMOVE) IS NOT SUSPECTED TO HAVE A RISK OF HAIR LOSS.

    Description of Event or Problem · 1

    PATIENT WROTE COMPLAINT LETTER TO THE HOSPITAL STATING THAT SHE HAD EXPERIENCED SIGNIFICANT HAIR LOSS WHERE THE EEG ELECTRODES HAD BEEN GLUED TO HER HEAD (ON THE SEIZURE MONITORING UNIT). PATIENT HAD BEEN HOSPITALIZED FOR 8 DAYS AND NOTED THE HAIR LOSS AFTER SHE WAS HOME FROM THE HOSPITAL. PATIENT ALSO E-MAILED SEVERAL PICTURES OF THE BALD SPOTS ON HER HEAD (WHERE ELECTRODES HAD BEEN GLUED). PATIENTS SIGN A FORM DESCRIBING THE RISKS OF EPILEPSY MONITORING, WHICH SPECIFICALLY STATES THAT "....SMALL PATCHES OF HAIR ARE SOMETIMES LOST." HOWEVER, THE PATIENT'S PICTURES SHOW MORE THAN SMALL PATCHES OF HAIR WERE LOST. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? CONTINOUS EEG MONITORING FOR SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLODIAN SKIN PREPARATION IAW MAVIDON MEDICAL PRODUCTS COLODIAN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other