CONTIGEN? BARD? COLLAGEN IMPLANT 651005

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-03 for CONTIGEN? BARD? COLLAGEN IMPLANT 651005 manufactured by C.r. Bard, Inc. (covington) -1018233.

Event Text Entries

[116034502] 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 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 catheterization. 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, 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.
Patient Sequence No: 1, Text Type: N, H10


[116034503] It was reported in the patient? S medical records that as a result of having the product implanted, the patient has experienced mixed urinary incontinence, overactive bladder, urgency, pain, rectocele (prolapse), dysuria, urinary frequency, erosion, urinary tract infection, itching, nocturia, cystitis, unstable bladder, atrophic vaginitis, difficulty emptying bladder, additional surgical and nonsurgical interventions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2018-03304
MDR Report Key7748602
Report SourceOTHER
Date Received2018-08-03
Date of Report2018-08-03
Date Mfgr Received2018-07-26
Date Added to Maude2018-08-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANGELA ROBINSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1C.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal Code30014
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTIGEN? BARD? COLLAGEN IMPLANT
Generic NameCONTIGEN? BARD? COLLAGEN IMPLANT
Product CodeLNM
Date Received2018-08-03
Model NumberNA
Catalog Number651005
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (COVINGTON) -1018233
Manufacturer Address8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-08-03

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