UNKNOWN PELVICOL PRODUCT
Report
- Report Number
- 9617613-2016-00123
- Event Type
- Injury
- Date Received
- November 22, 2016
- Date of Event
- December 5, 2003
- Report Date
- October 25, 2017
- Manufacturer
- COVIDIEN, FORMERLY TISSUE SCIENCE LABOR
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
TRACKING NUMBER: (B)(4). E2: PHONE NUMBER : (B)(6). G2: PHONE NUMBER: (B)(4). EXEMPTION NUMBER: E2013003. COVIDIEN IS SUBMITTING THIS REPORT OF BEHALF OF C.R. BARD, INC., (IMPORTER). C.R. BARD REFERENCE NUMBER: (B)(4).
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED PAIN, DISCOMFORT, URINARY PROBLEMS, AND DYSPAREUNIA. PATIENT HAS REQUIRED ADDITIONAL SURGICAL INTERVENTIONS. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
MEDTRONIC COMPLAINT REPORT: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM, IF FOLLOW-UP, WHAT TYPE?, EVALUATION CODES, DATE RECEIVED BY MFR, TYPE OF REPORTS.
PER ADDITIONAL INFORMATION RECEIVED THE PROCEDURE WAS A TRANSVAGINAL SLING PROCEDURE WITH CYSTOCELE REPAIR, CYSTOSCOPY. CONCOMITANT DEVICE: IN FAST ULTRA KIT.
IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED INJURY, PAIN, DISCOMFORT, URINARY PROBLEMS, DYSPAREUNIA, ADDITIONAL SURGERIES, EROSION, AND URINARY INCONTINENCE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773710 | UNKNOWN PELVICOL PRODUCT | MESH, SURGICAL, POLYMERIC | FTL | COVIDIEN, FORMERLY TISSUE SCIENCE LABOR | UNK PELVICOL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other |