BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARDS/SOLCOTRANS PLUS DRAINAGE/REINFUSION SYSTEM

    MDR report key: 5948 · Received January 28, 1993

    Report

    Report Number
    1020279-1993-00002
    Event Type
    Injury
    Date Received
    January 28, 1993
    Report Date
    January 7, 1993
    Manufacturer
    SOLCO BASLE, INC.
    Product Code
    DQI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DTHAT THE WOUND DRAIN BROKE IN THE JOINT WHEN THE SURGEON ATTEMPTED TO REMOVE THE DRAIN. SUBSEQUENTLY, THE SURGEON HAD TO OPEN THE PATIENT TO REMOVE THE DRAINDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARDS/SOLCOTRANS PLUS DRAINAGE/REINFUSION SYSTEM DRAINAGE/REINFUSION SYSTEM DQI SOLCO BASLE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention