BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL VHSD 5CC EU

    MDR report key: 1900783 · Received November 16, 2010

    Report

    Report Number
    2954761-2010-00045
    Event Type
    Injury
    Date Received
    November 16, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION REGARDING THIS CASE IS AVAILABLE. THIS IS THE FIRST COMPLAINT OF THIS NATURE RECEIVED FOR THIS PRODUCT LOT. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4).FOR A FINAL EVALUATION OF THE CAUSAL RELATIONSHIP OF THE ALLERGY WITH THE USE OF FLOSEAL FOLLOWING CLINICAL QUESTIONS HAVE TO BE CLARIFIED:1. TYPE OF PRODUCT USED (FLOSEAL WITH BOVINE OR HUMAN THROMBIN)?2. WHAT ASSOCIATED MEDICATION (WITH IMMUNOGENIC POTENTIAL) HAS BEEN ADMINISTERED DURING SURGERY, BEFORE THE SYMPTOMS OCCURRED?3. DECHALLENGE: HAS THE APPLIED PRODUCT BEEN REMOVED AFTER THE OCCURRENCE OF THE CLINICAL SYMPTOMS?4. HAVE ANY TEST OF IGG AND IGE BEEN PERFORMED, AND IF ?YES? WITH WHAT RESULTS.5. FOR CONFIRMATION OF AN ALLERGIC REACTION THE EVALUATION OF ANTI-BOVINE IGG AND IGE WOULD BE CRITICAL.6. IF ALLERGIC REACTION CONFIRMED AN ALLERGOLOGICAL TESTING OF THE PATIENT TO BOVINE PROTEINS IS IMPORTANT (TO PREVENT THE RISK OF FURTHER RE-EXPOSURES)7. WHAT WAS THE COURSE OF THE COMPLICATION AFTER THE TRANSFER TO THE ICU AND WHAT TREATMENT WAS INITIATED?IN A PRELIMINARY EVALUATION WE CONCLUDE THAT AN ALLERGIC REACTION IS POSSIBLE, AND A CAUSAL RELATIONSHIP WITH THE USE OF FLOSEAL CANNOT BE EXCLUDED.(B)(4) ,MD SAFETY OFFICER----------------A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE NEW INFORMATION CONFIRMS THAT THE PRODUCT USED CONTAINED HUMAN THROMBIN WHICH FURTHER DECREASES THE LIKELIHOOD THAT THIS IS AN ALLERGIC REACTION TO THE PRODUCT. THE INCIDENCE OF ALLERGIC REACTION TO GELATIN IS EXTREMELY RARE, HOWEVER WITHOUT SPECIFIC SENSITIVITY TESTING TO BOVINE GELATIN A CAUSAL RELATIONSHIP WITH THE USE OF FLOSEAL CANNOT BE EXCLUDED. (B)(6).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT ON AN UNCONFIRMED DATE A PATIENT SUFFERED AN ALLERGY FOLLOWING A LAPAROSCOPY CHOLECYSTECTOMY WHERE FLOSEAL WAS USED. SURGEON IS UNSURE IF ALLERGY IS DUE TO PRODUCT; NO DETAILS OF REACTION WERE PROVIDED. CUSTOMER WOULD LIKE ANY CLINICAL DETAILS / PAPERS ON REPORTED ALLERGIC REACTIONS WITH FLOSEAL.NO DETAILS OF DATA OR BATCH NUMBER SUPPLIED AT TIME OF LOGGING. -----------------ADDITIONAL INFORMATION PROVIDED BY BAXTER (B)(4) ON 15-NOV-2010:REACTION ? ABNORMAL LIVER FUNCTION TESTS POST-OP, MILD JAUNDICE, AND ELEVATED CRP. PATIENT INITIALS: (B)(6)GENDER: MALEDOB: (B)(6)LOT NUMBER: HA100415

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM BAXTER (B)(4) ON (B)(6) 2010: ANTIBIOTICS WERE USED AS A ONE-OFF DOSE DURING THE OPERATION BUT APART FROM THAT NO OTHER POSSIBLE IMMUNOGENIC MATERIAL HAS BEEN USED OR LEFT IN-SITU. THE PRODUCT HAS NOT BEEN REMOVED (AFTER THE OCCURRENCE OF THE CLINICAL SYMPTOMS) AS IT IS IN THE GALL BLADDER BED AND SHOULD HAVE DISSOLVED ETC. LGG TESTS AND IGE TESTS WERE DONE BY A CONSULTANT GASTROENTEROLOGIST. THE EVALUATION DETERMINED THAT WAS AN ALLERGIC REACTION. THE PATIENT WAS NOT TRANSFERRED TO ICU. THIS EMERGED AS A FEVER, COUGH AND EOSINOPHILIA WHILE THE PATIENT WAS NOT IN THE HOSPITAL AND RECOVERING SLOWLY FROM A STANDARD LAPAROSCOPIC CHOLECYSTECTOMY DUE TO A MUCOCOELE AND INFLAMMATION. ADDITIONAL INFORMATION RECEIVED FROM THE BAXTER MANUFACTURING FACILITY ON (B)(4) 2010: THIS PRODUCT LOT CONTAINS HUMAN THROMBIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL VHSD 5CC EU AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD HA100415

    Patients

    Seq Age Sex Outcome Treatment
    1 Other