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Catalog Number 651005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Burning Sensation (2146); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
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: ¿worsened incontinence; urinary retention; urinary tract infection; and/or localized responses (including swelling, erythema, induration, infection, necrosis, abscess formation, and/or hypersensitivity response). Two hundred thirty-nine (239) adverse events were reported over a five-year period by 154 patients from a group of 382 patients participating in a multicenter evaluation of contigen implant. 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 20% 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 9% of patients and generally was managed with clean intermittent catherization. Urethritis and bladder outlet obstruction occurred in approximately 2% of treated patients, and less than 2% of male patients experienced balanitis. In the clinical evaluation, approximately 7% of patients treated experienced transient worsened incontinence (1-6 months), and approximately 3% 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 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. " (b)(4).
Event Description
The patient¿s attorney alleged a deficiency against the device. Per additional information received the patient has experienced, vulvar burning and itching, urinary leakage, pessary use, grade two cystocele, vulvar yeast, urge incontinence, questionable retention, not emptying well, pad use, vulvitis, urinary frequency, urinary urgency, vulvar abscess and vaginal prolapse and required multiple surgical and nonsurgical interventions.
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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
MDR Report Key9086348
MDR Text Key162448150
Report Number1018233-2019-05773
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P900030 S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 09/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2010
Device Catalogue Number651005
Device Lot NumberCVRF0002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Device Age3 MO
Event Location Hospital
Date Manufacturer Received08/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2007
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/19/2019 Patient Sequence Number: 1