FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19604904
·
Received June 25, 2024
Report
- Report Number
- 3003442380-2024-10119
- Event Type
- Malfunction
- Date Received
- June 25, 2024
- Date of Event
- March 7, 2024
- Report Date
- June 26, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1896135- MDR 3003442380-2024-10119- DEVICE 2 OF 2
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET FELL OFF EVENT ON (B)(6)-2024. NO FURTHER INFORMATION AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1280804 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female |