BEUDAMED
    FDA Adverse Event Summary report: N

    PACHMATE HANDHELD PACHYMETER

    MDR report key: 4795623 · Received May 22, 2015

    Report

    Report Number
    2522950-2015-00001
    Date Received
    May 22, 2015
    Date of Event
    January 1, 2015
    Report Date
    May 12, 2015
    Manufacturer
    DGH TECHNOLOGY, INC.
    Product Code
    IYO
    PMA / PMN Number
    K033385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP - ON 07/14/2015, (B)(6) (DGH) SPOKE WITH A REPRESENTATIVE FROM THE HOSPITAL WHERE THE EVENT TOOK PLACE. HE WAS INFORMED THAT ANTIBIOTICS WERE PRESCRIBED AS A PREVENTATIVE MEASURE. THE PATIENT RECOVERED WITH NO COMPLICATIONS OR PERMANENT IMPAIRMENT/DAMAGE. DGH 55 UNIT 2010-6925 WAS FOUND TO BE IN GOOD WORKING ORDER, HOWEVER A REPLACEMENT DEVICE WILL BE SENT TO THE CUSTOMER. DGH 55 UNIT 2010-6925 WILL BE MAINTAINED AT DGH.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION - INSPECTION OF THE 2 PROBES (SN (B)(4)) RETURNED WITH THE DGH 55 DEVICE (SN (B)(4)) DID NOT REVEAL ANY DEFORMATION OR DAMAGE THAT WOULD HAVE RESULTED IN THE PATIENT'S CORNEA BEING SCRATCHED. VISUAL INSPECTION OF DEVICE SHOWED NO OBVIOUS SIGNS OF NEGLECT/ABUSE. PROBE VERIFICATION - PROBE SN (B)(4) IS THE ORIGINAL PROBE PROVIDED WITH THE DEVICE AND WAS FOUND TO BE WITHIN SPECIFICATIONS FOR A NEW PROBE. PROBE SN (B)(4) IS THE REPLACEMENT PROBE PROVIDED BY THE DISTRIBUTOR. THE MEASURED PROBE OUTPUT WAS BELOW THE INITIAL SETUP TARGET FOR NEW PROBES, HOWEVER OUTPUT WAS WITHIN THE OPERATIONAL RANGE OF THE DEVICE. UNIT VERIFICATION - THE UNIT WAS CHECKED FOR MEASUREMENT ACCURACY USING DGH PACHYMETER MEASUREMENT STANDARD DEVICE (DPMSD) BOX #1. ALL READINGS WERE WITHIN TOLERANCE. ON EYE MEASUREMENTS WERE TAKEN USING THE DEVICE AND BOTH PROBES. THERE WAS NO INDICATION OF ANY DIFFICULTY IN OBTAINING MEASUREMENTS WITH THE DEVICE. CONCLUSION - DEVICE MISUSE. UNDER NO CIRCUMSTANCES SHOULD THE USER APPLY EXCESSIVE PRESSURE WHEN APPLANATING THE PROBE TO THE CORNEA.

    Description of Event or Problem · 1

    AN INTERNATIONAL DISTRIBUTOR SUBMITTED A RMA REQUEST THROUGH THE COMPANY WEBSITE ON (B)(6) 2015. WHILE INSPECTING THE DEVICE FOR REPAIR (B)(6) 2015 THE RMA WAS REVIEWED AND IT WAS FOUND THAT AN INJURY WAS DESCRIBED: " I HAVE A PACHMATE WITH A FAULT THAT I CANNOT SEEM TO REMEDY. THE CUSTOMER SAID TOO MUCH FORCE/PRESSURE IS NEEDED TO BE ABLE TO GET A MEASUREMENT. I COULD GET IT TO TAKE MEASUREMENTS ON MY HAND INTERMITTENTLY, ALTHOUGH I DON'T THINK DOING THIS IS THE BEST SIMULATION. AFTER FURTHER ISSUES WITH THE INSTRUMENT I SENT THE CUSTOMER A REPLACEMENT PROBE (BOTH PROBES WITH INSTRUMENT). NOT ONLY DID THE ISSUE PERSIST, BUT THE DOCTOR ALSO SCRATCHED THE PATIENT'S CORNEA DUE TO THE FORCE NEEDED TO TAKE A MEASUREMENT. I WOULD LIKE IF DGH COULD TAKE A LOOK AT THIS INSTRUMENT FOR ME. WOULD IT BE POSSIBLE TO GET AN RMA NUMBER AND CONSIDER A REPLACEMENT PROBE IF NECESSARY?" CURRENTLY PATIENT INFORMATION, OPERATOR INFORMATION DATE AND EXTENT OF INJURY IS UNKNOWN. IT IS ALSO UNKNOWN IF ANY MEDICAL TREATMENT OR INTERVENTION WAS REQUIRED DUE TO THE INJURY.

    Description of Event or Problem · 1

    AT THE TIME THIS REPORT WAS FIRST SUBMITTED, IT WAS UNKNOWN THE EXTENT OF THE INJURY. ON 07/14/2015, (B)(6) (DGH) WAS ABLE TO CONTACT THE HOSPITAL WHERE THE EVENT TOOK PLACE. HE WAS INFORMED THAT ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT AS A PREVENTATIVE MEASURE. THE PATIENT RECOVERED WITH NO COMPLICATIONS OR PERMANENT IMPAIRMENT/DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337460 PACHMATE HANDHELD PACHYMETER PACHYMETER, 90 IYO IYO DGH TECHNOLOGY, INC. DGH 55

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention