FDA Adverse Event
Malfunction
Summary report: N
ARTOURA PLUS, SMOOTH, HIGH PROFILE
MDR report key: 18893157
·
Received March 13, 2024
Report
- Report Number
- 18893157
- Event Type
- Malfunction
- Date Received
- March 13, 2024
- Date of Event
- January 4, 2024
- Report Date
- January 5, 2024
- Manufacturer
- MENTOR TEXAS LP
- Product Code
- LCJ
- UDI-DI
- 10081317028243
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
ATTENDING MD (MEDICAL DOCTOR) TESTED IMPLANT FOR LEAKS BEFORE IMPLANTING EXPANDER AND NOTED THERE WAS A LEAK. IMPLANT WAS NOT USED ON PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1212682 | ARTOURA PLUS, SMOOTH, HIGH PROFILE | EXPANDER, SKIN, INFLATABLE | LCJ | MENTOR TEXAS LP | SDC-130H | 9981228 | 10081317028243 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |