FDA Adverse Event
Injury
Summary report: N
ADVANTAGE FIT SYSTEM
MDR report key: 3063642
·
Received April 17, 2013
Report
- Report Number
- 3005099803-2013-02520
- Event Type
- Injury
- Date Received
- April 17, 2013
- Report Date
- March 25, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- OTN
- PMA / PMN Number
- K020110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT ON JUNE 08, 2016 STATED THAT THE PATIENT EXPERIENCED INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 166381 | ADVANTAGE FIT SYSTEM | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR | OTN | BOSTON SCIENTIFIC - MARLBOROUGH | M0068502111 | ML00000105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |