BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN® BARD® COLLAGEN IMPLANT

    MDR report key: 5996732 · Received October 4, 2016

    Report

    Report Number
    1018233-2016-01332
    Event Type
    Injury
    Date Received
    October 4, 2016
    Report Date
    September 21, 2016
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    LNM
    PMA / PMN Number
    P900030 S011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: UROLOGICAL APPLICATIONS. ADVERSE EVENTS ASSOCIATED WITH TREATMENT MAY INCLUDE BUT ARE NOT LIMITED TO: WORSENED INCONTINENCE; URINARY RETENTION; URINARY TRACT INFECTION; AND/OR LOCALIZED RESPONSES (INCLUDING SWELLING, ERYTHEMA, INDURATION, INFECTION, NECROSIS, ABSCESS FORMATION, AND/OR HYPERSENSITIVITY RESPONSE). IN THE CLINICAL EVALUATION OF CONTIGEN IMPLANT, TWO OF THE 78 TREATMENT-RELATED EVENTS (ONE EVENT OF URINARY RETENTION AND ONE PARA-URETHRAL ABSCESS) WERE THE RESULT OF LOCAL HYPERSENSITIVITY REACTIONS TO CONTIGEN IMPLANT. IN EACH CASE, THE PROBLEM RESOLVED WITHIN ONE MONTH WITHOUT LOSS OF EFFECTIVENESS. URINARY TRACT INFECTION OCCURRED IN APPROXIMATELY 20% OF TREATED PATIENTS. URINARY TRACT INFECTION OCCURRED MOST FREQUENTLY IN FEMALE PATIENTS AND GENERALLY WAS NOT RELATED TO TREATMENT. GENERALLY, THESE INFECTIONS RESOLVED WITH APPROPRIATE ANTIBIOTIC THERAPY AND WITHOUT SEQUELAE. URINARY RETENTION THOUGHT TO RESULT FROM OVERCORRECTION WITH CONTIGEN IMPLANT OCCURRED IN APPROXIMATELY 9% OF PATIENTS AND GENERALLY WAS MANAGED WITH CLEAN INTERMITTENT CATHETERIZATION. URETHRITIS AND BLADDER OUTLET OBSTRUCTION OCCURRED IN APPROXIMATELY 2% OF TREATED PATIENTS, AND LESS THAN 2% OF MALE PATIENTS EXPERIENCED BALANITIS. IN THE CLINICAL EVALUATION, APPROXIMATELY 7% OF PATIENTS TREATED EXPERIENCED TRANSIENT WORSENED INCONTINENCE (1-6 MONTHS), AND APPROXIMATELY 3% OF PATIENTS TREATED EXPERIENCED WORSENED INCONTINENCE WHICH DID NOT IMPROVE DURING STUDY PARTICIPATION. SLIGHT DISCOMFORT AND MILD BLEEDING WILL PROBABLY OCCUR AT THE INJECTION SITE IMMEDIATELY FOLLOWING THE INJECTION PROCEDURE. IN THE CLINICAL EVALUATION, APPROXIMATELY 2% OF TREATED PATIENTS REPORTED PAIN AT THE INJECTION SITE OR INJECTION SITE INJURY. TRANSIENT GROSS HEMATURIA MAY OCCUR IMMEDIATELY FOLLOWING THE INJECTION PROCEDURE. IN THE CLINICAL EVALUATION OF CONTIGEN IMPLANT, POSTPROCEDURE HEMATURIA OCCURRED IN APPROXIMATELY 2% OF TREATED PATIENTS. THE PATIENT SHOULD BE TOLD TO REPORT INCREASING DISCOMFORT OR SWELLING TO THE PHYSICIAN. (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING OPENED IN ASSOCIATION WITH THE ALLEGED EVENT FILED BY THE PATIENT'S ATTORNEY IN COMPLAINT NUMBER (B)(4). THERE HAVE BEEN NO ALLEGATIONS OF DEFICIENCY OR SERIOUS INJURY AGAINST THIS DEVICE. THIS DEVICE IS LISTED IN THE PATIENT'S MEDICAL RECORDS RECEIVED ON (B)(6) 2016. IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INFECTION, MESH EROSION, MESH EXTRUSION, PELVIC PAIN, URINE LEAKAGE, IRRITABLE BLADDER, OVERACTIVE BLADDER, CALCULUS IN BLADDER (CALCIFICATION, FOREIGN BODY IN PATIENT), URINARY TRACT INFECTION, URGE INCONTINENCE, WEIGHT LOSS, BACK PAIN, SCARRING, BLOOD, LEUKOCYTES, WHITE AND RED BLOOD CELLS/NITRITES/BACTERIA IN URINE, UNABLE TO URINATE, PYURIA, DYSURIA, GLYCOSURIA, HEMATURIA, BLOOD LOSS, ESCHERICHIA COLI/PROTEUS MIRABILIS/CORYNEBACTERIUM SPECIES/STAPHYLOCOCCUS SPECIES/LACTOBACILLUS IN URINE (BACTERIAL INFECTION), DYSPNEA, ADHESIONS, WEAKNESS, POOR APPETITE, VAGINAL BLEEDING, HYPERKALEMIA, GASTROESOPHAGEAL REFLUX DISEASE, VAGINAL PROLAPSE, HEMORRHAGIC CYSTITIS (INFLAMMATION), ABDOMINAL PAIN AND NONSURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648267 CONTIGEN® BARD® COLLAGEN IMPLANT CONTIGEN® BARD® COLLAGEN IMPLANT LNM C.R. BARD, INC. (COVINGTON) -1018233 N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention