FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19585780
·
Received June 21, 2024
Report
- Report Number
- 3003442380-2024-09529
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Date of Event
- May 19, 2024
- Report Date
- June 21, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018457
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1892699 - MDR 3003442380-2024-09529 - DEVICE 4 OF 10.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED TEN INFUSION SET FELL OFF EVENTS DURING USE. THE SET WAS USED FOR LESS THAN 24 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1156711 | TRUSTEEL | UNO CONTACT DETACH G29 80/6TCAP 10PK INT | FPA | UNOMEDICAL A/S | UNKNOWN | 5359459 | 05705244018457 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |