BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16119503 · Received January 8, 2023

    Report

    Report Number
    1423507-2023-00010
    Event Type
    Injury
    Date Received
    January 8, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 9, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    FQH
    PMA / PMN Number
    K202071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) MDR. BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT OR BATCH NUMBER WERE PROVIDED. A FOLLOW-UP WILL BE PROVIDED IF ADDITIONAL INFORMATION IS RECEIVED. FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG). DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGICAL SITE INFECTION THAT REQUIRED RE-OPERATION WAS OBSERVED, NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564594 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention