|
Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Incontinence (1928); Pain (1994); Depression (2361)
|
Event Type
Injury
|
Manufacturer Narrative
|
The sample was not returned.The finished product met all specifications prior to being released for general distribution.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.
|
|
Event Description
|
The patient's attorney alleged a deficiency against the device.Per additional information received, ((b)(6) 2015) the patient has experienced stress urinary incontinence, dyspareunia, bleeding and pain, ((b)(6) 2016) urine leakage, urinary incontinence, painful intercourse, depression, post-menopausal and required additional surgical and non-surgical interventions.
|
|
Search Alerts/Recalls
|
|
|