|
Catalog Number 651005 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Micturition Urgency (1871); Incontinence (1928); Injury (2348); Blood Loss (2597)
|
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).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).No sample received.
|
|
Event Description
|
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 implant sheet.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Per additional information received, the patient has experienced urgency, two unspecified defects, stress/urge urinary incontinence, frequency, vaginal discomfort, tired, interstitial cystitis, blood loss, intrinsic sphincter deficiency, discharge, vaginitis and nonsurgical and additional surgical interventions.
|
|
Search Alerts/Recalls
|
|
|