FDA Adverse Event
Injury
Summary report: N
TENSION FREE VAGINAL TAPE
MDR report key: 3113776
·
Received May 15, 2013
Report
- Report Number
- 2210968-2013-05584
- Event Type
- Injury
- Date Received
- May 15, 2013
- Report Date
- April 25, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K974098
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE IN 2005. WITHIN A YEAR POST PROCEDURE, THE PATIENT BEGAN TO EXPERIENCE REPEATED BLADDER INFECTIONS. THE PATIENT HAS BEEN TREATED WITH ANTIBIOTICS. THE PATIENT HAS SEEN THREE DIFFERENT PHYSICIANS FOR THE INFECTIONS AND IS DUE TO RETURN TO THE THIRD PHYSICIAN IN ANOTHER MONTH FOR FOLLOWUP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214968 | TENSION FREE VAGINAL TAPE | MESH, SURGICAL, POLYMERIC | FTL | ETHICON, INC. | NA | 1243115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |