|
Catalog Number 0112720 |
Device Problems
Defective Device (2588); Insufficient Information (3190)
|
Patient Problem
No Information (3190)
|
Event Type
Injury
|
Manufacturer Narrative
|
Currently, it is unknown whether the device may have caused or contributed to the reported event.The patient's attorney did not allege a specific device failure or patient injury and medical records were limited to the patient's implant op report and implant tracking log only.A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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.
|
|
Event Description
|
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2002 - the patient was diagnosed with a vaginal prolapse with a cystocele, stress urinary incontinence and intestinal adhesions secondary to previous surgery.The patient underwent an exploratory laparotomy, vaginal vault sacrocolpopexy with implant of a davol flat mesh, retropubic urethropexy by modified burch procedure, bilateral salpingo-oophorectomy and a modified moskowitz procedure.The attorney alleges the patient experienced an unspecified adverse outcome associated to the use of the device.
|
|
Search Alerts/Recalls
|
|
|