FDA Adverse Event
Injury
Summary report: N
ADVANTAGE FIT SYSTEM
MDR report key: 5615780
·
Received April 28, 2016
Report
- Report Number
- 3005099803-2016-01203
- Event Type
- Injury
- Date Received
- April 28, 2016
- Report Date
- February 26, 2016
- Product Code
- OTN
- PMA / PMN Number
- K020110
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
ATTACHMENT: [2016-04 EXEMPTION E2013036 SUBMISSION_OTN.XLS]
Additional Manufacturer Narrative · 0
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2013036 FOR PRODUCT CODE OTN.
Description of Event or Problem · 0
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2016-01201 AND 3005099803-2016-01202.
Description of Event or Problem · 0
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER ¿ E2013036 FOR PRODUCT CODE OTN. SUBMISSIONS FOR PRODUCT CODES OTP AND PAH CAN BE FOUND UNDER MANUFACTURER REPORTS NUMBERS 3005099803-2016-01201 AND 3005099803-2016-01202.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271118 | ADVANTAGE FIT SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | UNK777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |