FDA Adverse Event
Malfunction
Summary report: N
MIO
MDR report key: 19768600
·
Received July 18, 2024
Report
- Report Number
- 3003442380-2024-14832
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- June 6, 2024
- Report Date
- July 18, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244020030
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1914675 - MDR 3003442380-2024-14832 - DEVICE 4 OF 5. (B)(6).
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE EGYPT. IT WAS REPORTED THAT PATIENT FACED 5 INFUSION SET FELL OFF EVENT IN BETWEEN (B)(6) 2024. THE INFUSION SET WAS IN FOR 2 HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363667 | MIO | UNO INSET II 60/6 SC1 BLUE MIMX | FPA | UNOMEDICAL A/S | MMT-943A | 5411082 | 05705244020030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |