BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGISIS

    MDR report key: 7977742 · Received October 18, 2018

    Report

    Report Number
    1835959-2018-00011
    Event Type
    Injury
    Date Received
    October 18, 2018
    Report Date
    October 15, 2018
    Manufacturer
    COOK BIOTECH
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. PRODUCT NAME UNKNOWN; PRODUCT UNSPECIFIED. PRODUCT COMMON NAME UNKNOWN; PRODUCT UNSPECIFIED. 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 CODE PAJ / PAI. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. 510(K) UNKNOWN; PRODUCT UNSPECIFIED. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. BASED ON THE INFORMATION PROVIDED BY THE COMPLAINANT, DETAILS REGARDING A SPECIFIC CORRELATION BETWEEN THE UNSPECIFIED SURGISIS DEVICE'S PERFORMANCE AND THE ALLEGED INJURY REMAIN UNKNOWN. A ROOT CAUSE OF THE PATIENT'S ALLEGATIONS IS INCONCLUSIVE DUE TO THE LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THE COMPLAINT WILL BE REOPENED IF ADDITIONAL DETAILS ARE OBTAINED. THIS MDR IS RELATED TO (B)(6) REFERENCE # (B)(6).

    Description of Event or Problem · 1

    (B)(6) REFERENCE NO: (B)(6). PER THE PATIENT, A SURGISIS MESH PROLAPSE REPAIR DEVICE WAS IMPLANTED BY DR. (B)(6) OF (B)(6) HOSPITAL. THE PATIENT REPORTS EXPERIENCING PELVIC PAIN, FOREIGN BODY REACTION, NEEDING CORRECTIVE SURGERY , VOIDING DYSFUNCTION, NEUROMUSCULAR COMPLICATION, CHRONIC INFLAMMATION, EROSION, BLEEDING HAEMORRHAGE, BLADDER NERVE INJURY, AND UNCOMMON INFECTION. THE DEVICE IS STILL IMPLANTED. THE PATIENT INDICATES SHE WAS SERIOUSLY INJURED AND CURRENTLY UNDERGOING MANY SCANS DUE TO DAMAGE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821501 SURGISIS FTM COOK BIOTECH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability NONE REPORTED BY THE COMPLAINANT.