BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS

    MDR report key: 5008648 · Received August 17, 2015

    Report

    Report Number
    1835959-2015-00160
    Event Type
    Injury
    Date Received
    August 17, 2015
    Report Date
    August 13, 2015
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT PRODUCT NAME UNKNOWN; PRODUCT UNSPECIFIED PRODUCT COMMON NAME UNKNOWN; PRODUCT UNSPECIFIED LOT NUMBER NOT PROVIDED BY THE COMPLAINANT PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED 510(K) UNKNOWN; PRODUCT UNSPECIFIED AS REQUESTED BY THE FDA, WE HAVE MADE NOTE OF THE PRODUCT CODE IN SECTION. THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510(K), BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN, DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT PRODUCT NAME UNKNOWN; PRODUCT UNSPECIFIED PRODUCT COMMON NAME UNKNOWN; PRODUCT UNSPECIFIED LOT NUMBER NOT PROVIDED BY THE COMPLAINANT PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED 510(K) UNKNOWN; PRODUCT UNSPECIFIED AS REQUESTED BY THE FDA, WE HAVE MADE NOTE OF THE PRODUCT CODE IN SECTION . THE PRODUCT CODE LISTED IS NOT NECESSARILY THE PRODUCT CODE ASSIGNED TO THE DEVICE 510(K), BUT RATHER THE PRODUCT CODE THAT SEEMS THE MOST APPROPRIATE BASED ON THE SURGICAL PROCEDURE IN WHICH THE PRODUCT WAS IMPLANTED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN

    Description of Event or Problem · 1

    THE PATIENT WAS REPORTEDLY IMPLANTED WITH AN AMS SPARC AND AMS ELEVATE ANTERIOR ON (B)(6) 2010 AT (B)(6) MEDICAL CENTER IN (B)(6) BY DR. (B)(6). THE PATIENT WAS ALSO REPORTEDLY IMPLANTED WITH A SURGISIS DEVICE ON (B)(6) 2012 AT (B)(6) MEDICAL CENTER IN (B)(6) BY DR. (B)(6). THE PATIENT AND HER ATTORNEY HAVE ALLEGED THAT AS A RESULT OF THIS/THESE PRODUCT(S) BEING IMPLANTED IN THE PATIENT, THE PATIENT HAS EXPERIENCED PAIN, INJURY, AND HAS UNDERGONE MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543624 SURGISIS FTM COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1