FDA Adverse Event
Malfunction
Summary report: N
XPRESS LOPROFILE ENT DILATION SYSTEM
MDR report key: 23597829
·
Received November 19, 2025
Report
- Report Number
- MW5179074
- Event Type
- Malfunction
- Date Received
- November 19, 2025
- Date of Event
- September 22, 2025
- Report Date
- November 14, 2025
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- PNZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE BALLOON IN THE DEVICE FAILED TO INFLATE AND LIGHT DID NOT TURN ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2023820 | XPRESS LOPROFILE ENT DILATION SYSTEM | EUSTACHIAN TUBE BALLOON DILATION DEVICE | PNZ | STRYKER INSTRUMENTS | LPLF106 | 24292123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male |