BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

    MDR report key: 16152589 · Received January 12, 2023

    Report

    Report Number
    1423507-2023-00032
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 12, 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. 2B PROCODE: FQH (LAVAGE, JET) AND FRO (DRESSING, WOUND, DRUG).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DELAYED WOUND HEALING THAT REQUIRED MEDICAL INTERVENTION (RE-OPERATION) WAS OBSERVED, PROBABLE DEVICE RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963599 BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM SURGIPHOR FQH CAREFUSION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention