FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED
MDR report key: 20072793
·
Received August 26, 2024
Report
- Report Number
- 8021545-2024-03402
- Event Type
- Malfunction
- Date Received
- August 26, 2024
- Date of Event
- July 17, 2024
- Report Date
- November 24, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244022928
- 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 1951638 - DEVICE 2 OF 4. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: (B)(6).
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THIS MDR IS BEING SUBMITTED FOR AN UNKNOWN NUMBER OF DEVICES IN WHICH THE ISSUE WAS EXPERIENCED. ON (B)(6) 2024, REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT QUICK RELEASE. INFUSION SET HAS BEEN USED FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17434 | MEDTRONIC EXTENDED | UNO EWIS BLUE 60/6 HCAP 1-PK INT | FPA | UNOMEDICAL A/S | MMT-431AJ | 6006010 | 05705244022928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |