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

Catalog Number 651005

Device Problem Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Urinary Retention (2119); Weakness (2145); Discomfort (2330); Prolapse (2475)

Event Type  Injury  

Event Description

It was reported in the pt's medical records that as a result of having the product implanted, the pt has experienced urinary retention (increased pvr), suprapubic pressure, right sided inguinal pain, urinary urgency, frequency, cystitis of longstanding, burning/painful urination; mild stranding of the mesentery on the left with questionable inflammation such as mesenteric adenitis, a 4 mm right middle lobe lung nodule, probable small bilateral renal cysts, questionable focal thickening of the ascending colon, and question of right adnexal cyst versus normal right ovary (by ct- (b)(6) 2009); shooting vaginal/suprapubic pain, nocturia, first degree cystocele, recurrent stress urinary incontinence (coughing, sneezing or straining), recurrent uti's, abdominal/epigastric discomfort (starts in her right upper quadrant and extends into her back), mild right upper quadrant tenderness, immobile urethra, cervical tenderness, and urethral hypermobility, dribbling (with cough or sneeze), right groin area pain, air passing through urethra, right leg pain/weakness, mild tenderness along the right inguinal labial fold, and focal irritation within the obturator canal, unspecified infections, unspecified urinary problems, need to catheterize, unspecified recurrence of incontinence, and unspecified neuromuscular problems.

Manufacturer Narrative

The sample was not returned.Lot number is unk; 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.(b)(4).

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).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 (b)(4) 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 (b)(4) of patients and generally was managed with clean intermittent catheterization.Urethritis and bladder outlet obstruction occurred in approximately (b)(4) of treated patients, and less than (b)(4) of male patients experienced balanitis.In the clinical evaluation, approximately (b)(4) of patients treated experienced transient worsened incontinence (1-6 months), and approximately (b)(4) 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 (b)(4) 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 (b)(4) of treated patients.The patient should be told to report increasing discomfort or swelling to the physician.(b)(4).

• Brand Name: CONTIGEN BARD COLLAGEN IMPLANT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON; covington GA
• 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: 4106202
• MDR Text Key: 4761516
• Report Number: 1018233-2014-00235
• 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,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 65