BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEBBETTS FIBEROPTIC SS RETR 15CMX30MM

    MDR report key: 6572887 · Received May 17, 2017

    Report

    Report Number
    1038548-2017-00118
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    April 26, 2017
    Report Date
    July 10, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    FDG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 88-1088 TEBBETTS FIBEROPTIC RETRACTOR DEVICE WAS NOT RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED THE DEVICE WILL NOT BE RETURNING UNDER THE ADVISEMENT OF PROVIDENCE HEALTH RISK MANAGEMENT TEAM. A PHOTO WAS NOT PROVIDED. THE CUSTOMER ALSO DID NOT COMMUNICATE A LOT NUMBER FOR THE DEVICE; THEREFORE, THE DHR REVIEW COULD NOT BE PERFORMED. WITHOUT THE DEVICE TO CONFIRM AND EVALUATE THE REPORTED FAILURE, BD IS UNABLE TO DETERMINE THE ROOT CAUSE. IF THE DEVICE BECOMES AVAILABLE THE COMPLAINT WILL BE RE-OPENED AND A MORE THOROUGH INVESTIGATION WILL BE PERFORMED. CONCLUSION(S): OTHER- SAMPLE NOT RETURNED. THE CUSTOMER DID NOT RETURN PRODUCT FOR EVALUATION. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY

    Additional Manufacturer Narrative · 1

    (B)(4) ON 27APR2017 WRITER SENT THE CUSTOMER AN EMAIL ACKNOWLEDGING RECEIPT OF THE COMPLAINT, PROVIDING THE COMPLAINT TRACKING NUMBER AND REQUESTED FOLLOW UP INFORMATION INCLUDING AS TO IF THERE WAS ANY PATIENT IMPACT RELATED TO THIS EVENT. WRITER PROVIDED CONTACT INFORMATION. DEVICE NOT YET EVALUATED, IF THE DEVICE IS EVALUATED A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    SALES REP REPORTED VIA EMAIL: CUSTOMER WAS USING OUR FIBER OPTIC DEAVER RETRACTOR AND FIBER OPTIC CABLE THIS MORNING AND A PATIENT WAS BURNED AT THE CONNECTION OF THE RETRACTOR AND CABLE. SHE DID SAY THAT THE RETRACTOR WAS SET DOWN ON THE PATIENT AND A BURN OCCURRED. MULTIPLE PRODUCT CODES REPORTED AND CAPTURED IN ADDITIONAL RECORDS, (B)(4). NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353708 TEBBETTS FIBEROPTIC SS RETR 15CMX30MM RETRACTOR, FIBEROPTIC FDG CAREFUSION, INC 88-1088 WO115663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention