FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19838514
·
Received July 26, 2024
Report
- Report Number
- 3003442380-2024-16850
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- April 29, 2024
- Report Date
- July 26, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018129
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1922378 -MDR 3003442380-2024-16850 DEVICE 3 OF 8.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN SPAIN. PATIENT COMPLAINED ABOUT EIGHT INFUSION SETS FELL OFF. EVENT TOOK PLACE ON 29-APRIL-2024, 01-MAY-2024, 7-MAY-2024, 13-MAY-2024, 19-MAY-2024, 05-JUNE-2024, 09-JUNE-2024 AND 13-JUNE-2024. THE INFUSION SET WAS IN USE FOR FEW HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459514 | AUTOSOFT 90 | UNO INSET II 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002817 | 6004247 | 05705244018129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |