BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2063378 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00445
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 51559ISP MFG DATE: 09/01/2010, EXP DATE: 03/31/2015. BATCH 51620ISP MFG DATE: 09/02/2010, EXP DATE: 08/31/2015. BATCH J101146 MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. BATCH J101147 MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. BATCH J101148 MFG DATE: UNKNOWN, EXP DATE: UNKNOWN. BATCH J101422 MFG DATE: 05/01/2010, EXP DATE: 05/31/2015. BATCH J102219 MFG DATE: UNKNOWN, EXP DATE: UNKNOWN. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR BATCH NUMBERS 51559ISP, 51620ISP, J101146, J101147, AND J101422 WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/19/2011. (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH 51559ISP, MFG DATE: 09/01/2010, EXP DATE: 08/30/2015. BATCH 51620ISP, MFG DATE: 09/02/2010, EXP DATE: 08/31/2015. BATCH J101146, MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. BATCH J101147, MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. BATCH J101148, MFG DATE: 04/01/2010, EXP DATE: 04/30/2015. BATCH J101422, MFG DATE: 05/01/2010, EXP DATE: 05/31/2015. BATCH J102219, MFG DATE: 05/01/2010, EXP DATE: 05/31/2015. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT FEMORAL HEAD REPLACEMENT PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED AT THE ARTIFICIAL FEMORAL HEAD. THE SURGEON FIXATED THE DRAIN WITH SUTURE TO THE SKIN AND STARTED ACTIVATION. ON (B)(6) 2011, THE DRAIN WAS REMOVED IN THE WARD. DURING REMOVAL, THE DRAIN WAS BROKEN AT 1CM INTO THE INSERTION AREA, AND THE FRAGMENT (ABOUT 15CM) REMAINED IN THE PATIENT'S BODY. THE PATIENT UNDERWENT X-RAY EXAM TO CONFIRM THE PLACE OF THE FRAGMENT. ON (B)(6) 2011, THE FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY UNDER LOCAL ANESTHESIA IN THE OPERATION ROOM. THE PATIENT REMAINS HOSPITALIZED AND IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention