MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CONTIGEN BARD COLLAGEN IMPLANT

Catalog Number 651005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

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).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, post-procedure hematuria occurred in approximately 2% of treated patients.The patient should be told to report increasing discomfort or swelling to the physician.Summary of other applications (dermal) in dermal applications, sensitization reactions to injectable collagen implants have occurred in 1-2% of treated patients.Most reactions have been of a hypersensitivity nature and have consisted of erythema, swelling, induration and/or urticaria at implantation sites.Often these reactions have occurred following an unrecognized or unreported positive collagen skin test.On rare occasions, abscess formation has occurred at collagen implantation sites.In some cases these reactions have been associated with elevated titers of anti-bovine collagen antibodies, and reactions can be multiple or recurrent.These reactions develop weeks to months following injections and may result in induration and/or scar formation.Most of the remaining responses occurred in patients who became sensitized to collagen implants at some point during their course of treatment.In dermal applications of injectable collagens, allergic reactions typically persist between one and nine months, with an average duration of four months.These reactions may be intermittent or continuous in nature.In rare instances, reactions have resolved in one or two weeks, or have persisted for more than one year.Although several forms of therapy (antihistamines, nsaids, oral, topical, and intralesional steroids) have been tried, usually they resulted in only temporary improvement.In most cases, time has proven to be the determining factor in the resolution of these reactions.In rare instances, patients have been left with residual firmness at the site of a resolved adverse reaction.Systemic complaints have been reported in less than 1% of patients receiving injectable collagen implants.During clinical testing and subsequent monitoring of patient complaints following exposure to injectable crosslinked collagen implants in dermal applications, a variety of systemic complaints were reported.These reports included: flu-like symptoms (fever, headache, myalgia, neuralgia, nausea, malaise, or dizziness); pruritus; rash; transient visual disturbances including blurred vision; tingling and numbness; transient polyarthralgia; and various systemic diseases including immune-mediated diseases, such as rheumatoid arthritis, systemic lupus erythematosus, pm/dm, and scleroderma.Rare anaphylactoid responses have been reported, including acute episodes of hypotension, difficulty in breathing, tightness in chest, and/or shortness of breath.(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.

Event Description

It was reported in the patient's medical records that as a result of having the product implanted, the patient has experienced blood loss, exposure, back/pelvic/vaginal/groin pain, palpable mesh, ureteral injury, swelling (edema), cloudy/turbid urine, white blood cells/leukocytes in urine, red blood cells/blood in urine (hematuria), protein/nitrites/hyaline casts in the urine, hydronephrosis, hydroureter, nausea, vomiting, diarrhea, constipation, heaviness, epigastric pain, urinary tract infection (uti), leakage, right ureteral injury (injury), ureteral vaginal fistula (fistula), anemia, bruise/bleed easily, foreign body in patient, adhesions, chronic inflammation, hemorrhage, fibrosis, posterior wall irritation, ureteral extravasation, fullness of right collecting system, left kidney simple cysts, ureteral fluid collection around site of injury, gastrointestinal infection (infection), ureteral stricture, escherichia coli bacteremia (bacterial infection), scar-like changes, bacteria/coagulase negative staphylococcus in urine, wound dehiscence in vaginal mucosa (dehiscence of wound), leg/bladder spasms (muscle spasms), abdominal pain, sepsis, dyspareunia, urge/stress incontinence symptoms, urinary frequency, nocturia, weight loss (weight fluctuations), leakage of urine with strong urge to void/stress/coughing, urinary urgency, dysuria, sensation of incomplete emptying, irritability/hostility (emotional changes), anxiety, atrophic posterior vaginal stricture, vaginal outlet relaxation, malaise, fibromyalgia/myofascial pain (myalgia), insomnia (sleep disturbances), tired/sluggish/fatigue (fatigue), migraine/headache (headache), dizziness, urinary hesitancy, weakness, leg/feet pain, musculoskeletal stiffness, manic depression/bipolar disorder, unspecified urinary problems, spotting, burning on urination (burning sensation), restless leg syndrome, syncope (faint-syncope), delayed gastric emptying, urine retention, bladder distension, fever, chills, rib pain, poor appetite, night sweats (sweating), menopausal disorder, urine odor, and required additional surgical and non-surgical interventions.

• Brand Name: CONTIGEN BARD COLLAGEN IMPLANT
• Type of Device: CONTIGEN BARD COLLAGEN IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5230501
• MDR Text Key: 31411054
• Report Number: 1018233-2015-00480
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 651005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention