FDA Adverse Event
Injury
Summary report: N
PELVICOL PRODUCT
MDR report key: 3449107
·
Received November 1, 2013
Report
- Report Number
- 9617613-2013-01480
- Event Type
- Injury
- Date Received
- November 1, 2013
- Date of Event
- December 13, 2006
- Report Date
- October 24, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Additional Manufacturer Narrative · 1
TRACKING NUMBER: (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF C.R. BARD, INC., (IMPORTER). BARD TRACKING NUMBER: (B)(4).
Description of Event or Problem · 1
PROCEDURE: STRESS URINARY INCONTINENCE. ACCORDING TO THE REPORTER: THE PT ALLEGED INJURY.
Description of Event or Problem · 1
PATIENT HAS EXPERIENCED EROSION, MESH CONTRACTION, INFECTION, FISTULA, INFLAMMATION, SCAR TISSUE, ORGAN PERFORATION, DYSPAREUNIA, BLOOD LOSS, NERVE DAMAGE, PELVIC FLOOR DAMAGE, CHRONIC PAIN, AND OPERATIONS TO REMOVE MESH. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562414 | PELVICOL PRODUCT | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |