FDA Adverse Event
Other
Summary report: N
AEROGEN SYRINGES
MDR report key: 21060437
·
Received January 2, 2025
Report
- Report Number
- MW5164201
- Event Type
- Other
- Date Received
- January 2, 2025
- Report Date
- December 27, 2024
- Manufacturer
- AEROGEN LTD
- Product Code
- CAF
- Report Source
- Voluntary report
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AEROGEN SYRINGES LEAKING AND HAVING TO WASTE PRODUCT AND REMAKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431563 | AEROGEN SYRINGES | NEBULIZER (DIRECT PATIENT INTERFACE) | CAF | AEROGEN LTD | HM20110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |