BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAGEN PLUG - HELIPLUG 3/8 X 3/4 (1CM X 2CM)

    MDR report key: 3919125 · Received June 16, 2014

    Report

    Report Number
    2523190-2014-00035
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    LPG
    PMA / PMN Number
    P840062
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER STATING HE IS HAVING ALLERGIC REACTION TO HELI-PLUG. HELI-PLUG IS USED TO CONTROL BLEEDING AND DEVELOP BLOOD CLOTS IN EXTRACTION SITES. ON (B)(6) 2014, DENTIST PERFORMED FOUR EXTRACTIONS, SOCKET PRESERVATION BONE GRAFTING AND DELIVERED FLIPPERS. (B)(6) 2014: DENTIST REPORTS HEALING LOOKS VERY GOOD. (B)(6) 2014: PATIENT'S WIFE REPORTS THAT HER HUSBAND HAS BEEN IN BACKCOUNTRY OF (B)(6) SINCE LAST SEEN BY DENTIST. WHEN PATIENT FLEW BACK FROM (B)(6) GOT SEVERE HEART BURN (HAS BEEN TREATED FOR THAT IN THE PAST). HAS A RASH ALL OVER BODY THAT STARTED AFTER RETURN FROM (B)(6). PATIENT WAS ADMITTED TO HOSPITAL HAVING A SEVERE ALLERGIC REACTION. WIFE ASKED IF THIS COULD BE A REACTION TO BONE GRAFTING. DENTIST TOLD HER THAT HE DID NOT KNOW ANY INCIDENCE OF ALLERGIC REACTION BUT WOULD CHECK WITH MANUFACTURERS. (NO MDRS FOR THIS PRODUCT). SINCE NO SWELLING OR IRRITATION OF GUM TISSUE DENTIST FEELS THIS IS HIGHLY UNLIKELY. DENTIST DISCUSSED POSSIBILITY OF ALLERGY TO FLIPPER. USUALLY THERE WOULD BE CONTACT INFLAMMATION AND THIS WAS NOT SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352837 COLLAGEN PLUG - HELIPLUG 3/8 X 3/4 (1CM X 2CM) M54 - ORAL SURGERY LPG INTEGRA YORK, PA INC. 1134645

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization