BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 1659548 · Received April 12, 2010

    Report

    Report Number
    2210968-2010-00363
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 11, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAK
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). CELLULITIS. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE (B) (4) AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: MONOCRYL (POLIGLECAPRONE 25) SUTURE. PRODUCT CODE XAW3650, BATCH AK5BRQN MFG DATE: 09/15/2008, EXP DATE: 12/31/2013. PRODUCT CODE W3326, BATCH AL5DJXN, MFG DATE: 10/30/2008, EXP DATE: 12/31/2013. COATED VICRYL (POLYGLACTIN 910) SUTURE. PRODUCT CODE W9136, BATCH TL8CPBM5 MFG DATE: UNK, EXP DATE: UNK. PRODUCT CODE W9136 BATCH TL8CPBMO MFG DATE: 11/01/2004, EXP DATE: 12/31/2009. PRODUCT CODE W9136, BATCH TL8CPBM1 MFG DATE: 11/08/2004, EXP DATE: 12/31/2009. PRODUCT CODE W9136, BATCH TL8DCTM0 MFG DATE: 11/02/2004, EXP DATE: 12/31/2009. PRODUCT CODE W9136, BATCH TL8DCTM1 MFG DATE: 11/15/2004, EXP DATE: 12/31/2009. 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 A LEFT SIDE WIDE LOCAL EXCISION AND SENTINEL NODE BREAST BIOPSY PROCEDURE ON (B) (6) 2010. ON (B) (6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CELLULITIS OF THE LEFT BREAST. THE PATIENT WAS GIVEN IV ANTIBIOTICS BEGINNING (B) (6) 2010 UNTIL DISCHARGED ON (B) (6) 2010. THE ANTIBIOTICS INCLUDED FLUCLOXACILLIN (500 MG QDS) AND BENZYLPENNICILLIN (1-2G QDS). ORAL ANTIBIOTICS FLUCLOXACILLIN (500 MG QDS) AND PENICILLIN V (500MG QDS) WERE PRESCRIBED AT DISCHARGE. THE RESULTS OF THE WOUND CULTURE TAKEN ON (B) (6) 2010 WAS NO GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SUTURE PRODUCT SUTURE GAK ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention