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.Sample not returned.
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This complaint is being opened in association with the alleged event filed by the patient's attorney in complaint number (b)(4).There have been no allegations of deficiency or serious injury against this device.This device is listed in the patient's medical records.Per additional information received, the patient has experienced bloody discharge post collagen injection (discharge), stress urinary incontinence, pelvic relaxation, cystocele/rectocele (prolapse), low oxygen saturations post-operatively, coughing/frothy sputum post-operatively and required additional surgical and non-surgical interventions.
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