BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYRRELL IRIS HOOK

    MDR report key: 5788 · Received April 5, 1993

    Report

    Report Number
    1211999-1993-00010
    Event Type
    Injury
    Date Received
    April 5, 1993
    Date of Event
    January 22, 1993
    Report Date
    February 12, 1993
    Manufacturer
    UNKNOWN
    Product Code
    HNQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INFORMANT STATED THAT DURING USE OF THIS INSTRUMENT IN HAND SURGERY, THE SHARP TIP WAS ALLEGED TO HAVE BROKEN OFF. THE TIP WAS NOT LOCATED. THE INSTRUMENT WAS INTENDED, BY ITS LABELING TO BE USED IN EYE SURGERY. FACILITY INDICATED THAT THEY MAY HAVE FILED A USER REPORT. IT IS UNCERTAIN IF THE UERE FACILITY WILL RELEASE THE DEVICE FOR FULL IDENTIFICATION AND EVALUATION. THIS IS THE SECOND REPORT OF IMPROPER USE OF THE DEVICE FROM THIS USER FACILITYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. 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: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYRRELL IRIS HOOK Implant IRIS HOOK HNQ UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention