FDA Adverse Event
Malfunction
Summary report: N
MIO¿ ADVANCE
MDR report key: 19786249
·
Received July 20, 2024
Report
- Report Number
- 8021545-2024-02271
- Event Type
- Malfunction
- Date Received
- July 20, 2024
- Date of Event
- May 13, 2024
- Report Date
- July 20, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018877
- PMA / PMN Number
- K173879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(B)(6). PATIENT COUNTRY: FRANCE.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT EXPERIENCED ISSUE WITH INFUSION SET WAS FELL OFF DURING USE. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1918837 | MIO¿ ADVANCE | UNO MIO ADV. GREY 60/6 SC1 10-PK INT | FPA | UNOMEDICAL A/S | MMT-242A | 6003826 | 05705244018877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |