FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19676257
·
Received July 4, 2024
Report
- Report Number
- 3003442380-2024-11833
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- May 9, 2024
- Report Date
- July 5, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1903401 - MDR 3003442380-2024-11833 - DEVICE 3 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET FELL OFF EVENT ON 09-MAY-2024. THE INFUSION SET WAS IN USE FOR 2 HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1271816 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | UNKNOWN | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Male |