BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLORAPREP ONE STEP HI-LITE ORANGE

    MDR report key: 11361186 · Received February 22, 2021

    Report

    Report Number
    3004932373-2021-00064
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    February 9, 2021
    Report Date
    February 11, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE CUSTOMER. PRIMEVIGILANCE DID REACH OUT TO OBTAIN 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 CHLORAPREP CAUSES SKIN REACTIONS ON SHOULDERS, REDNESS AT THE SITE AND ON THE CHEST, CONCENTRATED IN THE ARM PIT AREA, WITH IT EXTENDING TO ONE PATIENT'S WRIST. PER EMAIL/PHONE CALL: I JUST SPOKE WITH (B)(6) AT (B)(6) (SORRY, DIDN'T GET THE MED CENTER NAME). HE WORKS IN THE OPERATING ROOM AND IS CALLING IN FOR A SURGEON RE: CHLORAPREP SKIN REACTIONS ON SHOULDERS. HE SAID THEY GET SINGLE CHLORAPREP FROM US AND ALSO PRE-PACKAGED CHLORAPREP, BUT HE ONLY HAD REF 930815 ON HAND TO GIVE ME A MATERIAL NO. HE SAYS THERE HAVE BEEN "MANY CASES" AND MULTIPLE SURGEONS REPORTING THAT SEVERAL DAYS AFTER SURGERY THERE WILL BE REDNESS AT THE SITE AND ON THE CHEST, CONCENTRATED IN THE ARM PIT AREA, WITH IT EXTENDING TO ONE PATIENT'S WRIST. HE DOES HAVE PICTURES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255441 CHLORAPREP ONE STEP HI-LITE ORANGE 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other