BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 12698717 · Received October 26, 2021

    Report

    Report Number
    3004932373-2021-00481
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 24, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    OJU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOS OF THE RASH ON THE LEG WERE RECEIVED BUT NOT OF THE SUSPECTED APPLICATOR IN QUESTION. AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE WAS DUE TO THE UNKNOWN CHLORAPREP USE. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AT THIS TIME. A PRODUCTION RECORD REVIEW COULD NOT BE COMPLETED AS NO BATCH/LOT INFORMATION WAS AVAILABLE. NO FURTHER ACTIONS ARE REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: A RASH OCCURRED AFTER SURGERY. VERBATIM: CONSUMER CALLED AND STATED, I HAD SURGERY ON OCTOBER 5TH AT THE (B)(6) SURGERY CENTER IN (B)(6). AFTER A COUPLE OF DAY I NOTICED A RASH. I THOUGHT IT WOULD GET BETTER WITH TIME BUT IT HAS GOTTEN WORSE. I DON'T THINK I SHOULD HAVE TO PAY FOR CREAM TREATMENT AND HERE WHAT I WANT. I WANT THE COMPANY TO SEND ME SOME HYDRORTISONE OVERNIGHT TO HELP ME WITH THE TREATMENT OF THIS RASH. I WANT THIS DONE URGENTLY !!NOTE: PICTURES WILL BE SENT IN BY THE CONSUMER VIA THE COMPLAINT EMAIL ADDRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: A RASH OCCURRED AFTER SURGERY . CONSUMER CALLED AND STATED, I HAD SURGERY ON OCTOBER 5TH AT THE (B)(6) CENTER IN (B)(6). AFTER A COUPLE OF DAY I NOTICED A RASH. I THOUGHT IT WOULD GET BETTER WITH TIME BUT IT HAS GOTTEN WORSE. I DON'T THINK I SHOULD HAVE TO PAY FOR CREAM TREATMENT AND HERE WHAT I WANT. I WANT THE COMPANY TO SEND ME SOME HYDROCORTISONE OVERNIGHT TO HELP ME WITH THE TREATMENT OF THIS RASH. I WANT THIS DONE URGENTLY. NOTE: PICTURES WILL BE SENT IN BY THE CONSUMER VIA THE COMPLAINT EMAIL ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599137 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL OJU CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other