FDA Adverse Event
Malfunction
Summary report: N
MIO¿ ADVANCE
MDR report key: 19786265
·
Received July 20, 2024
Report
- Report Number
- 8021545-2024-02273
- 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
E1: PATIENT CITY: (B)(4). PATIENT COUNTRY: FRANCE.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT ON 13-MAY-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 |
|---|---|---|---|---|---|---|---|
| 2033688 | MIO¿ ADVANCE | UNO MIO ADV. GREY 60/6 SC1 10-PK INT | FPA | UNOMEDICAL A/S | MMT-242A | UNKNOWN | 05705244018877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |