FDA Adverse Event
Injury
Summary report: N
UNKNOWN PELVICOL PRODUCT
MDR report key: 3143101
·
Received May 24, 2013
Report
- Report Number
- 9617613-2013-00289
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- June 29, 2001
- Report Date
- May 1, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TOT HE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Description of Event or Problem · 1
ALLEGED COMPLICATIONS POST DEVICE IMPLANT STRESS INCONTINENCE, CYSTOCELE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232257 | UNKNOWN PELVICOL PRODUCT | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |