BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 3812532 · Received May 15, 2014

    Report

    Report Number
    2210968-2014-06144
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 IN THE LITERATURE THAT A PATIENT WAS DIAGNOSED WITH RIGHT BASAL GANGLIA HEMORRHAGE AND UNDERWENT DEBRIDEMENT AND CRANIOTOMY DECOMPRESSION SURGERY ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. ALTHOUGH A SATISFACTORY EFFECT WAS ACHIEVED, THE PATIENT WAS HOSPITALIZED FOR GRAND MAL SEIZURES FIVE MONTHS LATER. SUBSEQUENT MAGNETIC RESONANCE IMAGING REVEALED AN INTRACRANIAL SPACE-OCCUPYING LESION. AFTER UNDERGOING EN BLOC RESECTION OF THE LESION, THE PATIENT WAS DIAGNOSED WITH AN ABSORBABLE HEMOSTAT RELATED INTRACRANIAL GIANT CELL GRANULOMA BY HISTOPATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291202 SURGICEL ABSORBABLE HEMOSTAT HEMOSTATIC AGENT, ABSORBABLE LMF ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R