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 Micturition Urgency (1871); Incontinence (1928); 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, 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.

Event Description

This complaint is being opened in association with the alleged event filed by the patient¿s attorney in complaint numbers (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.Per additional information received, the patient has experienced stress urinary incontinence, pain, unspecified urinary problems, recurrence, infection, bleeding, irritative voiding symptoms, mixed urinary incontinence, urinary tract infections, incomplete bladder emptying, urethrovesical junction with incomplete coaptation, urinary incontinence, frequency, urgency/urge incontinence, urinary leakage, functional incontinence, atrophic vulva/vaginal tissues, sore spots, dysuria, not eliminating balder irritants, vomits with ingestion of water, trouble sustaining contractions, pelvic floor weakness, post micturition dribbling, narrowing at the introitus, decreased muscle bulk at vaginal vault, shortening of pelvic floor muscles, peripheral edema, short of breath/lying down, itching, unusual weight gain/loss, abdominal/suprapubic pain, chills, sleep disorder, sweats, bed wetting, burring with urination (burning sensation), lower back pain, muscle cramps/weakness, stiffness, increased urine output, wheezing, gas bloating, up 3-5 times per night to void, distended bladder, atrophic vaginitis (inflammation), fecal incontinence, renal cyst, bladder decompressed by catheter/wall thickening, malodorous urine, yeast infection/dermatitis, dry mouth, blood in urine (hematuria), wide open urethra/pipe stem, collagen residual at bladder neck, urethral dysfunction, pain, red around stitches, pelvic/urethral pain, nocturnal enuresis, lightheadedness, dizziness, unquenchable thirst, detrusor instability, trabeculations, increased bladder sensation, decreased bladder capacity/compliance, weak stream, suture material midurethral area, high bladder neck, narrow/stenotic vagina, sphincter incompetency, quiescent bladder, scarring, hematoma, blood loss, urethral hypermobility, hiatal hernia, low red blood cell count/hemoglobin, diarrhea, unable to void/difficulty urinating, candidiasis of vulva/vagina (fungal infection), urinary retention, dizzy, low red blood cell/hemoglobin/hematocrit and required nonsurgical and additional 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: 5873069
• MDR Text Key: 52056792
• Report Number: 1018233-2016-01061
• 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
• Report Date: 07/27/2016

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: 07/27/2016
• Initial Date FDA Received: 08/12/2016
• 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
• Patient Age: 49 YR