BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMALE ROTATING COLLAR

    MDR report key: 6794120 · Received August 15, 2017

    Report

    Report Number
    1226348-2017-10596
    Event Type
    Injury
    Date Received
    August 15, 2017
    Date of Event
    May 23, 2017
    Product Code
    GAD
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI: PRODUCT MADE PRIOR TO COMPLIANCE DATE, UDI UNAVAILABLE; PRODUCT DISCONTINUED UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT IT IS POSSIBLE THAT CONNECTOR OF A LIGHTED RETRACTOR GETS HOT FROM THE LIGHT PHYSICS POINT OF VIEW. USER HAS TO BE AWARE OF THAT FACT AND CONTROL THE LIGHT SOURCE POWER APPROPRIATELY TO AVOID THIS CONDITION. IN ADDITION IT IS USERS RESPONSIBILITY TO AVOID DIRECT CONTACT WITH LIGHT SOURCE CONNECTOR. NOTE: THIS PRODUCT WAS DISCONTINUED 2005 AND WAS MANUFACTURED IN JULY 2003. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOWUP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS PERFORMING EXCHANGE OF RIGHT TISSUE-EXPANDER FOR SMOOTH ROUND GEL IMPLANT, RIGHT CAPSULOTOMY, DRAINING OF RIGHT LATISSIMUS DORSI FLAP DONOR SITE SEROMA, LEFT BREAST AUGMENTATION FOR SYMMETRY. AT END OF PROCEDURE WHEN DRAPES WERE REMOVED, A SUPERFICIAL 1CM X 3CM SECOND-DEGREE BURN ON LEFT UPPER ABDOMINAL WALL NOTED. THE CONNECTOR FOR THE LIGHTED RETRACTOR WAS SOMEWHAT HOT. ANTIBIOTIC OINTMENT AND NONSTICK GAUZE AND OCCLUSIVE DRESSING APPLIED AND PHYSICIAN AND OR MANAGER DISCLOSED INCIDENT TO PATIENT. NO FURTHER MENTION OF BURN/WOUND ON DISCHARGE DOCUMENTATION OR SUBSEQUENT HISTORY AND PHYSICAL ASSESSMENTS. CODMAN LIGHTED RETRACTOR, HANDLE - AF1 # 02264 003393; CORD# 073385; CONNECTOR # 243171 AND #030719474-001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576023 FEMALE ROTATING COLLAR RETRACTORS GAD

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention