|
Model Number UGYKA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Incontinence (1928); Injury (2348)
|
Event Type
Injury
|
Manufacturer Narrative
|
This event was previously reported to the fda on an alternative summary report (asr approval #: e2013038) which is no longer in effect.Because of additionally received complaint information, this and all further updates will be submitted through the 3500a form.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of symptomatic cystocele, stress urinary incontinence.It was reported that after implant, the patient experienced recurrence.Post-operative patient treatment included surgical intervention.The device had been used with sparc sling system.
|
|
Search Alerts/Recalls
|
|
|