BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFOAM SPONGE SIZE 12-7 PRODUCT CODE 1972

    MDR report key: 9785044 · Received March 4, 2020

    Report

    Report Number
    3008478369-2020-00021
    Event Type
    Injury
    Date Received
    March 4, 2020
    Report Date
    March 4, 2020
    Manufacturer
    FERROSAN MEDICAL DEVICES A/S
    Product Code
    LMF
    UDI-DI
    25712123000155
    PMA / PMN Number
    P990004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT COVERS PATIENT NO. 20 OUT OF 20 PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT. IT WAS REPORTED THAT SIMILAR EVENTS HAVE OCCURRED FOR AROUND 20 PATIENTS OVER A YEAR SPAN. THEREFORE, 20 INTERNAL REPORTS HAVE BEEN DONE AND ACCORDINGLY 20 REPORTS TO FDA ARE DONE. REFERENCE NUMBERS: FDA 3008478369-2020-00001, 3008478369-2020-00003, 3008478369-2020-00004, 3008478369-2020-00005, 3008478369-2020-00006, 3008478369-2020-00007, 3008478369-2020-00008, 3008478369-2020-00009, 3008478369-2020-00010, 3008478369-2020-00011, 3008478369-2020-00012, 3008478369-2020-00013, 3008478369-2020-00014, 3008478369-2020-00015, 3008478369-2020-00016, 3008478369-2020-00017, 3008478369-2020-00018, 3008478369-2020-00019, 3008478369-2020-00020. FERROSAN MEDICAL DEVICES A/S (B)(4).

    Description of Event or Problem · 1

    THIS REPORT COVERS PATIENT NO. 20 OUT OF 20. PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4)) FOR EVALUATION OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252773 SURGIFOAM SPONGE SIZE 12-7 PRODUCT CODE 1972 SURGIFOAM® SPONGE LMF FERROSAN MEDICAL DEVICES A/S 25712123000155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention