BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 661224 · Received January 9, 2006

    Report

    Report Number
    2210968-2006-00035
    Event Type
    Injury
    Date Received
    January 9, 2006
    Date of Event
    December 2, 2005
    Report Date
    December 11, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6 CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. DEVICE PRODUCT INSERT STATES THE DEVICE IS NON-ANTIGONIC, NON-PYROGENIC AND ELICITS ONLY A MILD TISSUE REACTION DURING ABSORPTION.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE DEVELOPED HIVES TWO WEEKS FOLLOWING BREAST AUGMENTATION SURGERY. SHE WAS SEEN IN THE ER AND GIVEN IV STEROIDS THEN DISCHARGED TO HOME ON PREDNISONE, DOXEPIN, TAGAMET, AND ZYRTEC. THE PATIENT STATES SHE WAS SEEN BY AN ALLERGIST WHO OPINES SHE HAD A DELAYED REACTION TO KEFLEX. THE REACTION OCCURRED 6 DAYS AFTER THE LAST DOSE OF KEFLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention KEFLEX