BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN

    MDR report key: 2933417 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00633
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    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). TISSUE ASPIRATED INTO DRAIN. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1227715, MFG DATE: NI, EXP DATE: NI. BATCH J1227716, MFG DATE: NI, EXP DATE: NI. BATCH J1125574, MFG DATE: NI, EXP DATE: NI.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1227715, MFG DATE: 02/01/2012, EXP DATE: 02/28/2017; BATCH J1227716, MFG DATE: 02/01/2012, EXP DATE: 02/28/2017; BATCH J1125574, MFG DATE: 01/01/2012, EXP DATE: 01/31/2017. 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS INSERTED. ON (B)(6) 2013, APPROXIMATELY 5 TO 7 DAYS POST OP, THE SURGEON ATTEMPTED TO REMOVE THE DRAIN. THE SURGEON FELT RESISTANCE SO A SMALL INCISION WAS MADE TO REMOVE THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38954 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention