FDA Adverse Event
Malfunction
Summary report: N
MIO ADVANCE
MDR report key: 19902209
·
Received August 3, 2024
Report
- Report Number
- 8021545-2024-02905
- Event Type
- Malfunction
- Date Received
- August 3, 2024
- Date of Event
- July 4, 2024
- Report Date
- August 4, 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
INITIAL AND FINAL MDR (B)(4). E1: PATIENT CITY: (B)(6).
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 6 INFUSION SETS LEAKAGE AT THE EVENT SITE ON 25-JUN-2024, 27-JUN-2024, 28-JUN-2024, 1-JUL-2024, 2-JUL-2024 AND 4-JUL-2024. THE INFUSION SET WAS IN USE FOR 1 DAY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951695 | MIO ADVANCE | UNO MIO ADV. GREY 60/6 SC1 10-PK INT | FPA | UNOMEDICAL A/S | MMT-242A | 6005392 | 05705244018877 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |