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Catalog Number 651005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Incontinence (1928); Unspecified Infection (1930); Itching Sensation (1943); Swelling (2091); Chills (2191); Hematuria (2558)
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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: 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).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.
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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 failed collagen implantation (failure of implant), stress urinary incontinence, left sided flank pain, bacteria, pyuria, white and red blood cells/leukocytes in urine, discomfort, hematuria, blood loss, anemia, pain with urination and dysuria, urgency, burning sensation, escherichia coli and enterococcus in urine (bacterial infection), recurrent urinary tract infections, leakage, hypermobile urethral and bladder neck, vaginal scarring, and nonsurgical and additional surgical interventions.
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Manufacturer Narrative
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(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.
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Event Description
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Per additional information received, the patient has experienced groin pain, itching, pain with intercourse, vaginal swelling, dyspareunia, vaginal spotting , tenderness, vaginal tissue thinning, migraines, fever, chills, nausea, vomiting, pain, pyelonephritis, reflux neuropathy and weight fluctuations.
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Search Alerts/Recalls
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