BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUMA DESENSITIZER POWER GEL

    MDR report key: 3895030 · Received June 25, 2014

    Report

    Report Number
    9610902-2014-00036
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    LBH
    PMA / PMN Number
    K093575
    Removal / Correction Number
    1925223-04/23/14-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. CONCLUSION: PRODUCT WAS DISPOSED OF BY OFFICE PRIOR TO CONTACTING THEM ABOUT THE RECALL. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. PRODUCT WAS DISPOSED OF BY OFFICE PRIOR TO CONTACTING THEM ABOUT THE RECALL. (B)(6) 2014 DEVICE EVALUATION FROM SAME LOT. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION. ASSISTANT CALLED ABOUT THE RECALL LETTER SHE RECEIVED. SHE SAID THAT THIS KIT WAS THE FIRST TIME THEY USED THE PRODUCT AND SHE HAD NOT LIKED IT BECAUSE OF THIS EXTRUSION ISSUE. SHE SAID THAT THEY DID NOT REALIZE THIS WAS NOT NORMAL AND WERE NOT GOING TO REORDER THIS PRODUCT. SHE SAID THAT IS WOULD COME OUT IN LARGE AMOUNTS AND GET ON THE PATIENT'S TISSUES. SHE SAID THAT THEY WOULD IMMEDIATELY RINSE IT OFF AND THAT NO HARM CAME TO ANY PATIENTS. SHE DID NOT REMEMBER THE DATES OR PATIENTS INVOLVED. SHE NO LONGER HAS THE PRODUCT ON THE OFFICE AS THEY USED EXCESSIVE AMOUNTS PER PATIENT AND THREW THE SYRINGES AWAY BEFORE NOTIFIED OF RECALL. FDA- THIS MALFUNCTION IS REPORTABLE AS SEC. 803.50 STATES: (A) IF YOU ARE A MANUFACTURER, YOU MUST REPORT TO US NO LATER THAN 30 CALENDAR DAYS AFTER THE DAY THAT YOU RECEIVE OR OTHERWISE BECOME AWARE OF INFORMATION, FROM ANY SOURCE, THAT REASONABLY SUGGESTS THAT A DEVICE THAT YOU MARKET: (2) HAS MALFUNCTIONED AND THIS DEVICE OR A SIMILAR DEVICE THAT YOU MARKET WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. ALSO THIS MATERIAL BATCH IS BEING RECALLED DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    UNCONTROLLED EXTRUSION. ASSISTANT CALLED ABOUT THE RECALL LETTER SHE RECEIVED. SHE SAID THAT THIS KIT WAS THE FIRST TIME THEY USED THE PRODUCT AND SHE HAD NOT LIKED IT BECAUSE OF THIS EXTRUSION ISSUE. SHE SAID THAT THEY DID NOT REALIZE THIS WAS NOT NORMAL AND WERE NOT GOING TO REORDER THIS PRODUCT. SHE SAID THAT IS WOULD COME OUT IN LARGE AMOUNTS AND GET ON THE PATIENT'S TISSUES. SHE SAID THAT THEY WOULD IMMEDIATELY RINSE IT OFF AND THAT NO HARM CAME TO ANY PATIENTS. SHE DID NOT REMEMBER THE DATES OR PATIENTS INVOLVED. SHE NO LONGER HAS THE PRODUCT ON THE OFFICE AS THEY USED EXCESSIVE AMOUNTS PER PATIENT AND THREW THE SYRINGES AWAY BEFORE NOTIFIED OF RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371398 GLUMA DESENSITIZER POWER GEL VARNISH,CAVITY LBH HERAEUS KULZER GMBH 010103

    Patients

    Seq Age Sex Outcome Treatment
    1