BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CHLORAPREP

    MDR report key: 11640412 · Received April 9, 2021

    Report

    Report Number
    3004932373-2021-00190
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    April 1, 2021
    Report Date
    August 23, 2021
    Manufacturer
    CAREFUSION 213, LLC 0113
    Product Code
    KXG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PN 270400, LOT NUMBER 0297917, MET ALL CHEMISTRY TESTING REQUIREMENTS PRIOR TO RELEASE AND TESTING RESULTS WERE WITHIN ACCEPTABLE SPECIFICATIONS. THE BATCH RECORD FOR THE LOT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND DURING THE MANUFACTURING OF THE LOT AND DURING ROUTINE QUALITY ASSURANCE INSPECTIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. FOLLOW UP EMDR (B)(4) H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    MATERIAL NO.: 270400 , BATCH NO.: 0297917. IT WAS REPORTED THAT THE PATIENT IS ALLERGIC TO CHLORAPREP. PER EMAIL: PLEASE SEE BELOW FOR DETAILS OF 1 X POTENTIAL AE. THE PATIENT HAS RETURNED THE SAMPLES TO OURSELVES, PLEASE LET US KNOW IF YOU WOULD LIKE THESE RETURNING TO YOURSELVES. PRODUCT: 270400 CHLORAPREP 2%CHG&70% (ST). BATCH: 0297917. DETAILS: PATIENT HAS RETURNED THE CHLORAPREP SAYING THEY CANNOT USE AS THEY ARE ALLERGIC.

    Additional Manufacturer Narrative · 1

    PR (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

    MATERIAL NO.: 270400. BATCH NO.: 0297917. IT WAS REPORTED THAT THE PATIENT IS ALLERGIC TO CHLORAPREP. PER EMAIL: PLEASE SEE BELOW FOR DETAILS OF 1 X POTENTIAL AE. THE PATIENT HAS RETURNED THE SAMPLES TO OURSELVES, PLEASE LET US KNOW IF YOU WOULD LIKE THESE RETURNING TO YOURSELVES. PRODUCT: 270400 CHLORAPREP 2%CHG&70% (ST). BATCH: 0297917. DETAILS: PATIENT HAS RETURNED THE CHLORAPREP SAYING THEY CANNOT USE AS THEY ARE ALLERGIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537716 UNKNOWN CHLORAPREP 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL KXG CAREFUSION 213, LLC 0113 0297917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other