BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODELB 110V ELECTRO DERMATOME COMPLETE KIT

    MDR report key: 5025409 · Received August 21, 2015

    Report

    Report Number
    3004608878-2015-00228
    Event Type
    Injury
    Date Received
    August 21, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 27, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    GFD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    0

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 21AUG2015: NO MEDICAL INTERVENTION WAS REQUIRED. SURGICAL INTERVENTION WAS REQUIRED. NO SURGICAL DELAY WAS REPORTED. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09/11/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINT HISTORY. RESULTS: CUSTOMER WAS UNSURE WHICH OF THE FOUR DEVICES SENT IN WERE INVOLVED IN THIS INCIDENT AS SUCH A DHR REVIEW WAS PERFORMED ON EACH: DEVICE 1 - SERIAL # (B)(4). DEVICE HISTORY RECORD REVIEWED FOR (B)(4) MANUFACTURED ON 04/12/1985 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR'S, VARIANCES OR REWORK. THIS DEVICE WAS LAST SERVICED ON 06/01/1995. DEVICE 2 - SERIAL # (B)(4). DEVICE HISTORY RECORD REVIEWED FOR (B)(4) MANUFACTURED ON 01/30/1984 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR'S, VARIANCES OR REWORK. THIS DEVICE WAS LAST SERVICED ON 09/08/1995. DEVICE 3 - SERIAL # (B)(4). DEVICE HISTORY RECORD REVIEWED FOR (B)(4) MANUFACTURED ON 01/08/1988 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR'S, VARIANCES OR REWORK. THIS DEVICE WAS LAST SERVICED ON 09/20/1993. DEVICE 4 -SERIAL # (B)(4). DEVICE HISTORY RECORD REVIEWED FOR (B)(4) MANUFACTURED ON 02/29/1988 SHOW NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR'S, VARIANCES OR REWORK. THIS DEVICE WAS LAST SERVICED ON 07/24/1995. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: CUSTOMER FORWARDED FOUR DEVICES FOR INSPECTION AS THEY WERE UNSURE WHICH OF THE FOUR DEVICES WERE INVOLVED IN THIS INCIDENT: DEVICE 1 - SERIAL # (B)(4). THE END USERS REASON FOR RETURN OF THIS DEVICE WAS VERIFIED AND THE MOST LIKELY REASON COULD BE THAT THE HEAD CALIBRATION WAS OUT OF TOLERANCE. LASTLY GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 1985 AND LAST SERVICED IN 1995. DEVICE 2 - SERIAL # (B)(4). THE END USERS REASON FOR RETURN OF THIS DEVICE WAS VERIFIED AND THE MOST LIKELY REASON COULD BE THAT THE HEAD CALIBRATION WAS OUT OF TOLERANCE. LASTLY GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 1984 AND LAST SERVICED IN 1995. DEVICE 3 - SERIAL # (B)(4). THE END USERS REASON FOR RETURN OF THIS DEVICE WAS VERIFIED AND THE MOST LIKELY REASON COULD BE THAT THE HEAD CALIBRATION WAS OUT OF TOLERANCE. LASTLY GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 1988 AND LAST SERVICED IN 1993. DEVICE 4 - SERIAL # (B)(4). THE END USERS REASON FOR RETURN COULD NOT BE DUPLICATED OR CONFIRMED HOWEVER GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 1988 AND LAST SERVICED IN 1995. LASTLY IT WAS OBSERVED THAT THIS DEVICE WAS SERVICED BY A NON-OEM.

    Description of Event or Problem · 1

    IT WAS REPORTED A SALES REPRESENTATIVE A DERMATOME TOOK A FULL THICKNESS GRAFT. STITCHES WERE REQUIRED. SALES REPRESENTATIVE RECOUNTS EVENT COMMUNICATIONS AS FOLLOWS - SHE WAS INITIALLY APPROACHED BY MATERIALS MANAGEMENT. THE MATERIALS MANAGEMENT PERSON STATED THE OPERATION ROOM MANAGER REPORTED TO HIM/HER A PROBLEM WITH THE DERMATOME BLADES. THERE WAS AN INJURY. THE SALES REPRESENTATIVE STATES SHE WAS TOLD PADGETT/INTEGRA DERMATOMES AND BLADES WERE USED/AVAILABLE FOR THIS PROCEDURE. THE SALES REPRESENTATIVE CAPTURED INFORMATION THAT THE OPERATION ROOM MANAGER FELT THE EVENT REPORTED REGARDING THE PATIENT INJURY WAS EXAGGERATED. NO ONE HAS BEEN WILLING TO CLARIFY OR GIVE MORE INFORMATION REGARDING PATIENT CONSEQUENCE UP TO THIS POINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL RISK MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555492 MODELB 110V ELECTRO DERMATOME COMPLETE KIT GFD INTEGRA LIFESCIENCES CORPORATION OH/USA MODEL B

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention