FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED INFUSION SET
MDR report key: 19496502
·
Received June 10, 2024
Report
- Report Number
- 8021545-2024-00937
- Event Type
- Malfunction
- Date Received
- June 10, 2024
- Date of Event
- April 30, 2024
- Report Date
- June 10, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244022805
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
PATIENT'S CITY: (B)(6). INITIAL AND FINAL MDR 1884422- MDR 8021545-2024-00937- DEVICE 6 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET CAME OFF AFTER EVERY SHOWER. MOREOVER, THE ISSUE OCCURRED WITH SIX INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149521 | MEDTRONIC EXTENDED INFUSION SET | UNO EWIS BLUE 60/9 HCAP 10PK INT | FPA | UNOMEDICAL A/S | MMT-441A | UNKNOWN | 05705244022805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |