BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP UNKNOWN

    MDR report key: 11910769 · Received May 31, 2021

    Report

    Report Number
    3004932373-2021-00265
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 25, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PARKVIEW NOBLE HOSPITAL. 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 BY THE SALES REPRESENTATIVE THAT THE PATIENT EXPERIENCED A RASH AFTER USE OF CHLORAPREP. HAVE EITHER OF YOU HEARD OF RECENT ISSUES WITH CHLORAPREPS? [NURSE] BROUGHT TO MY ATTENTION 2 SHOULDER SCOPES THAT DR COMPLETED ON (B)(6) 2021; BOTH HAD COMPLAINTS REDNESS, RASH DOWN THEIR ARMS. ANDREA SAW THEM IN THE OFFICE AND SHE DESCRIBES IT AS "HAIRFOLLICLES BEING INFECTED; ALMOST LIKE A SKIN CELLULITIS; BUMPY RED RASH; ONE LADY'S SKIN WAS PEELING OFF HER NECK". THE INCISION SITES LOOK GOOD, BUT THECHLORAPREP IS BEING WASHED OFF AFTER THE CASE AROUND THE INCISION BEFORE DRESSED. I QUESTIONED IF IT COULD POSSIBLY BE THE PREP, BUT THEN THESE ARE THE FIRST 2 I HAVE HEARD LIKE THIS. DURING AN ORTHO TOUCH BASE CALL THIS MORNING, [NURSE] TOLD ME THAT SHE REACHED OUT TO A NURSE AT ONE AND SHE COMMUNICATED THAT THEY HAVE BEEN SEEING ISSUES AS WELL, BUT WITH A DIFFERENT SURGEON'S SHOULDER SCOPE PATIENTS. I KNOW IT SOUNDS BIZARRE, BUT COULD IT POTENTIALLY BE THE CHLORAPREPS? HAVE YOU HEARD OF THESE ISSUES AT ANY OTHER FACILITY? THANKS FOR THE NOTIFICATION. I HAVE COPIED THE CHLORAPREP REP WITH THIS EMAIL, SO WE DO NEED TO BE CAREFUL WITH HIPAA INFO GOING FORWARD. I PERSONALLY, HAVE NOT HAD ANYONE TELL ME WHAT YOU ARE SAYING BELOW. SOME THINGS TO CONSIDER IS THE CLIPPING¿WAS IT THE SAME PERSON CLIPPING ON THE PATIENTS WHO EXPERIENCED THE RASH? I AM ASSUMING PEOPLE ARE USING THE CLIPPER AND NOT A RAZOR, BUT IT WOULD BE GOOD TO ENSURE THE CLIPPING IS DONE PER THE MFG INSTRUCTIONS. ATTACHED IS THE INSERVICE POSTER. I ALSO WOULD LIKE TO KNOW THE LOT NUMBER IF IT IS POSSIBLE. WAS IT THE SAME SIZE AND LOT NUMBER PREP? SO ANY OTHER DETAILS WOULD BE NICE TO KNOW. ITIS INTERESTING IT IS SCOPE PATIENTS. SAM, ANY OTHER THOUGHTS OR INFO YOU NEED? OVER THE PAST COUPLE OF MONTHS, WE'VE DONE EDUCATION WITH STAFF REGARDING CLIPPER PREPPING. WE ALWAYS CLIPPER PREP; NOT RAZOR. INTERESTING ENOUGH THIS IS WHAT I FOUND WITH OUR 3 SHOULDER SCOPE PATIENTS. 1 PATIENT WITH A RASH WHOSE SKIN WAS VISIBLY PEELING ON HER NECK DIDN'T HAVE A CLIPPER PREP. 1 PATIENT WITH A RASH HAD A DRY CLIPPER PREP. 1 PATIENT WITHOUT ANY COMPLAINTS POST OP HAD A WET CLIPPER PREP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803290 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