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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 CONTIGEN® BARD® COLLAGEN IMPLANT Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Micturition Urgency (1871); Incontinence (1928)
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).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, post procedure 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).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
It was reported in the patient's medical records that as result of having the product implanted, the patient has experienced hypermobile urethra, leakage, pelvic floor hypermobility, unstable contractions, mixed (stress and urge) incontinence, cough, urgency, trace blood and leukocytes in urine, blood loss, pain, inability to have sex, erosion, dyspareunia, chills, dizziness, numbness, tingling, abdominal pain, elevated blood pressure, rash, urinary frequency, pain with urination (dysuria), depression, discomfort, and required nonsurgical and additional surgical interventions.
 
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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 Key6882336
MDR Text Key87157722
Report Number1018233-2017-04918
Device Sequence Number1
Product Code LNM
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 Attorney
Type of Report Initial
Report Date 09/21/2017
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 Model NumberN/A
Device Catalogue Number651005
Device Lot NumberUNKNOWN
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 08/28/2017
Initial Date FDA Received09/21/2017
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 Number1
Patient Outcome(s) Required Intervention;
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