BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBBER DAM PUNCH

    MDR report key: 10715798 · Received October 21, 2020

    Report

    Report Number
    2523190-2020-00118
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 23, 2020
    Report Date
    September 24, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EJG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D10, G4, G7, H2, H3, H6, H10. UDI#: (B)(4). THE RUBBER DAM PUNCH WAS NOT RETURNED (DISCARDED BY CUSTOMER) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). 766A RUBBER DAM PUNCH WAS RECEIVED FOR EVALUATION. THE RETURNED RUBBER DAM PUNCH WAS IN USED CONDITION WITH THE TIP BROKEN OFF DUE TO PHYSICAL DAMAGE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TIP OF THE 766A RUBBER DAM PUNCH BROKE OFF IN A PATIENT'S MOUTH DURING AN UNSPECIFIED DENTAL PROCEDURE ON (B)(6) 2020. THEY WERE ABLE TO RETRIEVE IT WITHOUT CAUSING HARM TO THE PATIENT. THERE WAS NO KNOWN DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180548 RUBBER DAM PUNCH M51 - GENERAL DENTISTRY EJG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1