BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIGEN BARD® COLLAGEN IMPLANT

    MDR report key: 4992149 · Received August 11, 2015

    Report

    Report Number
    1018233-2015-00291
    Event Type
    Injury
    Date Received
    August 11, 2015
    Report Date
    July 27, 2015
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    LNM
    PMA / PMN Number
    P900030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. 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). 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). NO SAMPLE RECEIVED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED, PAIN, EXTRUSION, UNSPECIFIED URINARY PROBLEMS, ORGAN PERFORATION, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING (SCARRING), EROSION, INFECTION, UNSPECIFIED BOWEL PROBLEMS, ADHESIONS, URINARY STRESS INCONTINENCE, INTERNAL SPHINCTER DEFICIENCY, CHRONIC INTERSTITIAL CYSTITIS (INFLAMMATION), SUPRAPUBIC/ABDOMINAL PAIN (ABDOMINAL PAIN), LUMBAGO, URINARY FREQUENCY, URINARY URGENCY, DYSURIA, BLADDER CALCULUS, FOREIGN BODY IN BLADDER (FOREIGN BODY IN PATIENT), ULCERATIVE COLITIS (ULCERATION), CALCIFICATION, ALLERGIES, ABNORMAL GAIT, OVERDOSE, PARTIAL SMALL BOWEL OBSTRUCTION (OBSTRUCTION), INFLAMMATORY MASS IN COLON, STRICTURES, SCAR TISSUE, MIXED PORTAL INFLAMMATION, INTERLOBULAR BILE DUCT INJURY, PERIDUCTAL HISTIOCYTES, STEATOHEPATITIS/STEATOSIS, PERISINUSOIDAL/PORTAL/SEPTAL FIBROSIS (FIBROSIS), ELEVATED LIVER FUNCTION STUDIES, ACUTE AND CHRONIC SEROSITIS, LYMPH NODE REACTIVE CHANGES, CHOLELITHIASIS, ADENOMYOSIS OF GALLBLADDER WALL, BLOOD LOSS, AND REQUIRED ADDITIONAL SURGICAL AND NON-SURGICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527309 CONTIGEN BARD® COLLAGEN IMPLANT COLLAGEN IMPLANT LNM C.R. BARD, INC. (COVINGTON) CVRA0028

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention CONTIGEN BARD COLLAGEN IMPLANT