BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11668944 · Received April 15, 2021

    Report

    Report Number
    3004932373-2021-00198
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 9, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PR (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY SURGERY CENTER OF (B)(6). PRIMEVIGILANCE DID REACH OUT TO OBTAIN MORE INFORMATION WITH NO SUCCESS. SHOULD ADDITIONAL INFORMATION BE AVAILABLE IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. ALL COMPLAINTS ARE REVIEWED DURING MONTHLY QUALITY/SAFETY MEETINGS. IN ADDITION, COMPLAINTS ARE TRENDED AT MONTHLY QUALITY DATA ANALYST MEETINGS AND QUARTERLY PLANT MANAGEMENT REVIEW MEETINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS DEVELOPED A RASH AROUND THE SURGICAL INCISION SITE AFTER USE OF CHLORAPREP. PER EMAIL: PRODUCT CATALOG NUMBER: 930815. PRODUCT DESCRIPTION: APPLICATOR 2% CHG 70% ISOPRPNL 1 STEP APL 26ML ORNG HI-LT. ORIGIN OF THE ISSUE: PATIENT SAFETY. DETAIL: WE HAVE RECEIVED REPORTS OF PATIENTS GOING HOME AND THEN DEVELOPING A RASH (SMALL RED BUMPS THAT ITCH). THE SURGICAL INCISIONS LOOK NORMAL, IT IS ALWAYS THE AREA AROUND THE INCISIONS THAT THE RASH IS LOCATED. THE TYPE OF CASES VARY; THREE ORTHOPAEDIC CASES THAT INVOLVED THE KNEE AND ONE GYNECOLOGY CASE IN WHICH THE ABDOMEN WAS PREPPED. RASH NOTED TO BE LOCATED IN THE SURGICAL PREP AREAS IN EVERY CASE. LOT # IS NOT LISTED AS WE HAVE VARIOUS LOT NUMBERS FOR THE PREP HERE AT THE CENTER AND THE SPECIFIC LOT NUMBER USED IN EACH CASE WAS NOT DOCUMENTED. WE HAVE STARTED AS OF 3/25/21 DOCUMENTING THE LOT NUMBER FOR REFERENCE TO ANY FUTURE ISSUES. PREP STICKS IN HAND AND ARTHROSCOPIC PACKS ARE THE SAME PREP STICKS WE HAVE INDIVIDUALLY STOCKED ON THE SHELF. REPORTED TO VENDOR REPRESENTATIVE. NUMBER OF OCCURRENCES: 4.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571368 CHLORAPREP UNKNOWN 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other