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

Model Number N/A

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

Patient Problems Erosion (1750); Diarrhea (1811); Urinary Tract Infection (2120); Urinary Frequency (2275)

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.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.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.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 received.

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, infection, erosion, extrusion, pain during intercourse/dyspareunia, vaginal bleeding, foreign body in patient, unspecified urinary problems, urinary tract infection, pelvic floor irritation, urinary frequency, nocturia, intermittency, sensation of incomplete emptying, stones, kidney infections, irritation, exposure, loose stool, heaviness in vagina, migraines, headaches, genital atrophy, cystocele (prolapse), vaginal sensitivity, urethral hypermobility, mesh bulging through vaginal wall, incontinence, irritative symptoms, difficulty voiding, escherichia coli in urine/blood, urosepsis infection, itching, blood/bacteria/red blood cells/leukocytes/nitrites/white blood cells/mucus in urine, staphylococcus in urine, kidney scarring, back pain, fever, chills, back ache, decreased appetite, pyelonephritis, fatigue, flank pain, elevated white blood cells, low calcium/sodium/potassium (electrolyte imbalance), abdominal pain, swelling, bruising, drainage, anemia, discomfort, atrophic vaginitis, depression, bradycardia, burning sensation, constipation, spotting, non-surgical and additional surgical interventions.

Manufacturer Narrative

(b)(4).

Event Description

Per additional information received, the patient has experienced recurrent urinary tract infections, mixed incontinence, trouble emptying bladder, urge incontinence, urosepsis with positive blood cultures (x2), diarrhea, body aches, recurrent stress urinary incontinence, recurrent cystocele and discomfort with intercourse due to mesh protrusion (dyspareunia), nonsurgical and surgical interventions such as, oral and intravenous antibiotics, prophylactic nitrofurantoin, cystoscopy on (b)(6) 2008, cystoscopy, removal of previously placed (ams monarc) mesh, repair of cystocele with mesh, and placement of tvt (bard align r) on (b)(6) 2008.

• 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); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6399417
• MDR Text Key: 69794882
• Report Number: 1018233-2017-01046
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900030 S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

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 Expiration Date: 08/31/2009
• Device Model Number: N/A
• Device Catalogue Number: 651005
• Device Lot Number: CVQK0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2006
• 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
• Treatment: CONTIGEN® BARD® COLLAGEN IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79