BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABOTAMP SNOW ABS

    MDR report key: 9258425 · Received October 30, 2019

    Report

    Report Number
    2210968-2019-89267
    Event Type
    Injury
    Date Received
    October 30, 2019
    Report Date
    October 1, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS: CITATION: ACTA NEUROCHIRURGICA (2018); 160:2069¿2075. DOI: HTTPS://DOI.ORG/10.1007/S00701-018-3663-0.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: INTRACRANIAL FOREIGN MATERIAL GRANULOMAS AFTER CRANIAL SURGERY. AUTHORS: SHADI AL-AFIF, GOKCE HATIPOGLU MAJERNIK, ELVIS JOSEF HERMANN, MAJID. ESMAEILZADEH, CHRISTIAN HARTMANN, JOACHIM K. KRAUSS. CITATION: ACTA NEUROCHIRURGICA (2018); 160:2069¿2075. DOI: HTTPS://DOI.ORG/10.1007/S00701-018-3663-0 THE AUTHORS PRESENTED A SERIES OF 12 PATIENTS WITH TUMEFACTIVE FOREIGN BODY GRANULOMAS AFTER PRIOR CRANIAL SURGERY DOCUMENTED OVER A PERIOD OF 13 YEARS. A TOTAL OF 12 PATIENTS (6 MALE AND 6 FEMALE; MEAN AGE: 51 YEARS; AGE RANGE: 11¿68 YEARS) WITH FOREIGN BODY GRANULOMAS INDUCED BY SYNTHETIC MATERIAL USED IN A PRIOR SURGERY WERE IDENTIFIED. PATIENT 3, A 39-YEAR OLD MALE PATIENT WHO UNDERWENT PARTIAL RESECTION OF A FRONTAL LOBE LOW-GRADE GLIOMA AND USED OXIDIZED CELLULOSE POLYMER (TABOTAMP; ETHICON) AND DEVELOPED FOREIGN BODY GRANULOMA WITH SIGNS AND SYMPTOMS OF NEW ONSET OF RIGHT-SIDED HEMIOHYPESTHESIA AND HEADACHE. IN ALL CASES, TOTAL RESECTION OF THE GRANULOMA WAS ACHIEVED USING DEPARTMENTAL STANDARD TECHNIQUES FOR MICROSURGERY, NAVIGATION, AND MONITORING. MR IMAGING STUDIES WITH GADOLINIUM AT FOLLOW-UP SHOWED NO RECURRENCE OF THE FOREIGN BODY GRANULOMAS IN ALL INSTANCES. SYMPTOMS IMPROVED IN ALL SYMPTOMATIC PATIENTS. DESPITE ITS RARITY, FOREIGN BODY GRANULOMA SHOULD BE TAKEN INTO CONSIDERATION IN THE DIFFERENTIAL DIAGNOSIS OF INTRACRANIAL MASS LESIONS ESPECIALLY IN CASES OF SUSPECTED TUMOR RECURRENCE AFTER PRIOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051622 TABOTAMP SNOW ABS HEMOSTATIC AGENT, ABSORBABLE LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention