FDA Adverse Event
Malfunction
Summary report: N
BYRON
MDR report key: 1804225
·
Received August 6, 2010
Report
- Report Number
- 1645337-2010-00022
- Event Type
- Malfunction
- Date Received
- August 6, 2010
- Date of Event
- July 19, 2010
- Report Date
- August 5, 2010
- Manufacturer
- BYRON MEDICAL, INC.
- Product Code
- MUU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
BLUE HANDLED METAL REUSABLE LIPOSUCTION CANNULA TIP BROKE OFF INSIDE PT. TIP WAS RETRIEVED USING C-ARM FLUOROSCOPY. PROCEDURE WAS EXTENDED 30 - 45 MINUTES AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BYRON | LIPOSUCTION CANNULA | MUU | BYRON MEDICAL, INC. | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |