BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UW RUB. DAM CLAMP FCPS

    MDR report key: 10782684 · Received November 3, 2020

    Report

    Report Number
    2523190-2020-00126
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    October 7, 2020
    Report Date
    October 8, 2020
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EJG
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). RUBBER DAM CLAMPS WERE NOT RETURNED FOR EVALUATION (THEY PURCHASED ADDITIONAL RUBBER DAM CLAMPS AS A REPLACEMENT); HOWEVER, IMAGE WAS PROVIDED AND EVALUATED: PER THE PROVIDED IMAGE, THESE 76-15 FORCEPS ARE IN USED CONDITION WITH THE TIPS BROKEN OFF DUE TO ROUGH HANDLING OR EXCESSIVE FORCE. THE REPORTED COMPLAINT IS CONFIRMED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. ADDITIONAL INFORMATION RECEIVED - THERE WAS A DELAY FOR 20 MINUTES BECAUSE TOOTH NUMBER 24 INCISAL LINGUAL EDGED WAS CHIPPED WHEN THE CLAMPS BROKE.

    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

    IT WAS REPORTED THE RUBBER DAM CLAMP FORCEPS BROKE DURING A DENTAL PROCEDURE RESULTING IN A CHIPPED LOWER LATERAL TOOTH. THE PATIENT WAS COMPLAINING OF PAIN AND DISCOMFORT AND THE TOOTH WAS REPAIRED WITH FILLING. THE BROKEN PIECE WAS RETRIEVED, AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241294 UW RUB. DAM CLAMP FCPS M51 - GENERAL DENTISTRY EJG INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1