BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIFOAM SPONGE SIZE 12-7 PRODUCT CODE 1972

    MDR report key: 9773884 · Received March 2, 2020

    Report

    Report Number
    3008478369-2020-00011
    Event Type
    Injury
    Date Received
    March 2, 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. 10 OUT OF 20 PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00002 (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 FERROSAN MEDICAL DEVICES A/S 3008478369-2020-00001 (B)(4). 3008478369-2020-00003 (B)(4). 3008478369-2020-00004 (B)(4). 3008478369-2020-00005 (B)(4). 3008478369-2020-00006 (B)(4). 3008478369-2020-00007 (B)(4). 3008478369-2020-00008 (B)(4). 3008478369-2020-00009 (B)(4). 3008478369-2020-00010 (B)(4). 3008478369-2020-00011 (B)(4). 3008478369-2020-00012 (B)(4). 3008478369-2020-00013 (B)(4). 3008478369-2020-00014 (B)(4). 3008478369-2020-00015 (B)(4). 3008478369-2020-00016 (B)(4). 3008478369-2020-00017 (B)(4). 3008478369-2020-00018 (B)(4). 3008478369-2020-00019 (B)(4). 3008478369-2020-00020 (B)(4). 3008478369-2020-00021 (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT COVERS PATIENT NO. 10 OUT OF 20 PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00001 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: QN (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 FERROSAN MEDICAL DEVICES A/S 3008478369-2020-00001 (B)(4). 3008478369-2020-00003 (B)(4). 3008478369-2020-00004 (B)(4). 3008478369-2020-00005 (B)(4). 3008478369-2020-00006 (B)(4). 3008478369-2020-00007 (B)(4). 3008478369-2020-00008 (B)(4). 3008478369-2020-00009 (B)(4). 3008478369-2020-00010 (B)(4). 3008478369-2020-00011 (B)(4). 3008478369-2020-00012 (B)(4). 3008478369-2020-00013 (B)(4). 3008478369-2020-00014 (B)(4). 3008478369-2020-00015 (B)(4). 3008478369-2020-00016 (B)(4). 3008478369-2020-00017 (B)(4). 3008478369-2020-00018 (B)(4). 3008478369-2020-00019 (B)(4). 3008478369-2020-00020 (B)(4). 3008478369-2020-00021 (B)(4).

    Description of Event or Problem · 1

    THIS REPORT COVERS PATIENT NO. 10 OUT OF 20 PLEASE REFER TO FDA REPORT NO.: 3008478369-2020-00002 (INTERNAL FERROSAN MEDICAL DEVICES A/S REPORT NO.: (B)(4) FOR EVALUATION OF THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT COVERS PATIENT NO. 10 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
    241094 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