FDA Adverse Event
Malfunction
Summary report: N
MIO
MDR report key: 19736745
·
Received July 13, 2024
Report
- Report Number
- 3003442380-2024-14369
- Event Type
- Malfunction
- Date Received
- July 13, 2024
- Date of Event
- June 12, 2024
- Report Date
- July 13, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1911260 - MDR 3003442380-2024-14369 - DEVICE 4 OF 4. E1: PATIENT CITY: (B)(4). PATIENT COUNTRY: CANADA.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 12-JUN-2024, IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET LEAKAGE EVENTS SINCE JANUARY-2024. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903568 | MIO | UNO INSET 30 60/13 SC1 GREY MCAN | FPA | UNOMEDICAL A/S | MMT-905A600 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |