BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-COMB

    MDR report key: 221311 · Received April 29, 1999

    Report

    Report Number
    MW1016220
    Event Type
    Injury
    Date Received
    April 29, 1999
    Date of Event
    April 27, 1999
    Report Date
    April 29, 1999
    Manufacturer
    HEALTH ENT., INC.
    Product Code
    LJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHILD CAUGHT HEAD LICE AT SCHOOL. SHE WAS TREATED WITH APPROPRIATE SHAMPOO AND FOLLOWING THE INSTRUCTIONS ON THE COMB, WITH ONE EXCEPTION, THE MOTHER PROCEEDED TO COMB THROUGH THE CHILD'S HAIR AND ALL OF THE HAIR IN THE COMB WAS CUT OFF. THE ONE EXCEPTION TO THE INSTRUCTIONS WAS "USING THE RIGHT HAND". THE MOTHER IS LEFT HANDED AND THEREFORE USING THE RIGHT HAND WOULD HAVE BEEN MORE AWKWARD AND DAMAGING. THE MOTHER CONSULTED HER PEDIATRICIAN AND PHARMACIST TO ENSURE THAT THE INCIDENT WAS NOT RELATED TO THE SHAMPOO. BOTH HCP'S REPORTED NO EXPERIENCE OF THIS SORT. IN AN ATTEMPT TO RULE OUT THE SHAMPOO, THE MOTHER REPEATED THE PROCEDURE ON HER OWN HAIR USING REGULAR SHAMPOO. THE RESULT WAS THE SAME, HER HAIR WAS CUT OFF BY THE COMB. THE RPTR STATED, THE DEVICE MFR TOLD HER THAT THE INCIDENT OCCURRED BECAUSE SHE HAD USED HER LEFT HAND. THE RPTR FINDS THIS TO BE UNACCEPTABLE AND FEELS THAT THERE SHOULD BE ADD'L LABELING OR THE PRODUCT SHOULD BE REMOVED FROM THE MARKET. RPTR STATES THE ONLY WARNING ON THE PRODUCT IS "DO NOT FORCE MEDI-COMB THROUGH HAIR. USE CAUTION TO AVOID SCRATCHING THE SCALP." THE PHARMACY, THE RPTR PURCHASED THE COMB FROM REMOVED THE STOCK FROM HER SHELF AFTER EXAMINING THE COMB AND FINDING IT TO BE SHARP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-COMB METAL LICE COMB LJL HEALTH ENT., INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR KWELL SHAMPOO.