BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT

    MDR report key: 1062459 · Received June 17, 2008

    Report

    Report Number
    2210968-2008-00446
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    January 1, 2007
    Report Date
    May 22, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    LMF
    PMA / PMN Number
    N12159
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 06/17/2008. 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 THE SURGEON USED THE ABSORBABLE HEMOSTAT DURING A SCOLIOSIS PROCEDURE AND LEFT THE PRODUCT IN SITU. POSTOPERATIVELY THE PATIENT DEVELOPED ACUTE CHEMICAL PANCREATITIS. THE PATIENT'S AGE WAS BETWEEN 13-16 YEARS AND IN WEIGHT FORM 37KG - 60 KG. THE ACUTE PANCREATITIS OCCURRED 4-5 DAYS POST OPERATIVELY. THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND VOMITING. THERE WAS AN INCREASE IN HER AMYLASE, LIPIDS AND LIVER ENZYME LEVELS. THIS EVENT REQUIRED HOSPITALIZATION WITH IV FLUID THERAPY AND GASTRIC DRAIN FOR 2-3 DAYS. THE PATIENT RECOVERED WITH COMPLETE RESOLUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention