BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.00 READING GLASSES

    MDR report key: 4758568 · Received May 5, 2015

    Report

    Report Number
    MW5042556
    Event Type
    Other
    Date Received
    May 5, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 20, 2015
    Manufacturer
    DIAMOND VISION, INC.
    Product Code
    HQZ
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER PURCHASED A PAIR OF READING GLASSES ON (B)(6) 2015 FROM HARDWARE STORE IN MICHIGAN. ON (B)(6) 2015 SHE PICKED THE GLASSES UP WHEN DREW BACK BECAUSE SHE HAD TOUCHED ON A VERY SHARP AREA AT THE NOSE PIECE. ON EACH SIDE OF THE BAR CONNECTING THE GLASS EYE AREA, THERE IS A SHARP POINTED OBJECT. THERE ARE TWO OTHER SHARP POINTED OBJECTS ON EACH SIDE OF THE NASAL GRIPS OF THE GLASSES. THESE SHARP PIECES ARE ON THE SIDE THAT IS PLACED ON THE FACE. NOT ON THE OUTSIDE. ON (B)(6) 2015 THE CALLER RETURNED TO THE PLACE OF PURCHASE TO RETURN THE GLASSES, SHE MET WITH (B)(6) WHO IS THE STORE MANAGER. SHE EXPLAINED TO HIM WHAT HAD HAPPENED WITH HER PAIR OF GLASSES THEN THEY BOTH SEARCHED THE RACKS LOOKING FOR GLASSES WITH THE SAME SHARP AREA. THEY BOTH SEARCHED THE RACKS FOR OTHER GLASSES WITH THESE SHARP POINTED PIECES, (B)(6) FOUND NONE BUT THE CALLER FOUND FOUR PAIRS AND GAVE THEM TO HIM. HE INFORMED HER THAT HE WAS PLANING TO PUT THEM IN HIS SAFE AND NOTIFY THE STORE'S CORPORATE OFFICE. SHE IS REPORTING THIS AS A LACERATION HAZARD. THERE ARE NO INJURIES KNOWN TO REPORT. SHE HAS NOT CONTACTED THE MANUFACTURER BECAUSE THEY ARE UNK TO HER AND SHE HAS NOT CONTACTED THE DISTRIBUTOR BECAUSE THEY ARE IN (B)(4). (B)(6). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295720 2.00 READING GLASSES NONE HQZ DIAMOND VISION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1