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Catalog Number 651005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Urinary Tract Infection (2120)
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Event Type
Injury
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Manufacturer Narrative
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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: "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.
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Event Description
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It was reported in the patient¿s medical records that as a result of having the product implanted, the patient has experienced overactive bladder symptoms, mixed incontinence, recurrent stress urinary incontinence, hematuria, recurrent urinary tract infections, frequency, urgency, dysuria, cystitis, having to wear pads, left nephrectomy for renal cell carcinoma, enuresis, saggy anterior wall of the vagina, hyperactive bladder, right flank pain, postmenopausal bleeding which required a dilatation and curettage, bladder fulguration, diffuse bladder inflammatory reaction, pressure when she urinated, nocturia, renal stones, incomplete bladder emptying, dyspareunia, urinary retention, smoking, and required nonsurgical interventions including medications and more urethral bulking.She also required surgical interventions consisting of a bard tension-free vaginal tape sling implant on (b)(6) 2008.Per additional information received the patient has experienced detrusor instability and detrusor overactivity.
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Search Alerts/Recalls
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