FDA Adverse Event
Malfunction
Summary report: N
MICROAIRE®
MDR report key: 23423510
·
Received October 30, 2025
Report
- Report Number
- 23423510
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- September 30, 2025
- Report Date
- October 10, 2025
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS LLC
- Product Code
- QPB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
WHEN STARTING TO OPEN FOR A CASE, WE PULLED OUT OUR DISPOSABLE LIPOSUCTION CANNULA, AND IT WAS BENT INSIDE THE PACKAGE. WE THEN WENT OUT TO GET ANOTHER ONE, AND THERE WAS ANOTHER ONE BENT IN THE C-LOCKERS. THE THIRD ONE WE PICKED UP WAS USEABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2409401 | MICROAIRE® | SYSTEM, SUCTION, LIPOPLASTY FOR REMOVAL | QPB | MICROAIRE SURGICAL INSTRUMENTS LLC | PAL-308LS | 105418052025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |