BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAHAM-FIELD PROFESSIONAL ANEROID

    MDR report key: 5350 · Received May 21, 1993

    Report

    Report Number
    32574-1993-00002
    Event Type
    Injury
    Date Received
    May 21, 1993
    Date of Event
    April 2, 1993
    Report Date
    April 26, 1993
    Manufacturer
    GRAHAM-FIELD, INC.
    Product Code
    DXQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A NURSING HOME NOTIFIED THIS DISTRIBUTOR THAT WHILE A CERTIFIED NURSE'S AIDE, AN EMPLOYEE OF THE NURSING HOME, WAS TAKING THE BLOOD PRESSURE OF A RESIDENT, THE BLOOD PRESSURE CUFF EXPLODED, AND HIS EAR DRUM ERUPTED, WHICH MAY ARESULT IN PERMANENT DAMAGE AND HEARING LOSS. TREATMENT MAY REQUIRE SURGERY. THE NURSING HOME REPORTED THAT THE BLOOD PRESSURE CUFF INVOLVED IN THIS INCIDENT WAS PART OF THE GRAHAM-FIELD MODEL NUMBER. PROFESSIONAL ANEROID MANUFACTURED BY GRAHAM-FIELD, INC. WHICH HAS BEEN NOTIFIED OF THE INCIDENTDEVICE NOT 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: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAHAM-FIELD PROFESSIONAL ANEROID BLOOD PRESSURE CUFF DXQ GRAHAM-FIELD, INC. #03-202 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention