ADVANTAGE FIT SYSTEM
Report
- Report Number
- 3005099803-2016-03381
- Event Type
- Injury
- Date Received
- October 27, 2016
- Report Date
- August 31, 2016
- Product Code
- OTN
- PMA / PMN Number
- K020110
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
ATTACHMENT: [2016-10 EXEMPTION E2013036 SUBMISSION_OTN.XLS]
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2013036 FOR PRODUCT CODE OTN.
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2013036 FOR PRODUCT CODE OTN.
THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES PAH AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2016-03382 AND 3005099803-2016-03380.
THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES PAH AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2016-03382 AND 3005099803-2016-03380.
THE MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES PAH AND OTP CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2016-03382 AND 3005099803-2016-03380.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713108 | ADVANTAGE FIT SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | UNK777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |