FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED
MDR report key: 19736649
·
Received July 13, 2024
Report
- Report Number
- 8021545-2024-02029
- 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
- UDI-DI
- 05705244023161
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1911590 - MDR 8021545-2024-02029 - DEVICE 2 OF 2. E1: PATIENT CITY: (B)(4). PATIENT COUNTRY: UNITED STATES.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SET FELL OFF EVENTS ON 12-JUN-2024. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 861509 | MEDTRONIC EXTENDED | UNO EWIS BLUE 60/6 HCAP 3-PK INT | FPA | UNOMEDICAL A/S | MMT-431AH | UNKNOWN | 05705244023161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |