FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 20094055
·
Received August 29, 2024
Report
- Report Number
- 3003442380-2024-22946
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Date of Event
- July 22, 2024
- Report Date
- July 30, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1953673 - MDR 3003442380- 2024 - 22946 - DEVICE 3 OF 5.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON (B)(4) 2024 FIVE INFUSION SET CANNULA WERE CRIMPED AND SITE OF INSERTION IS ABDOMEN. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1293892 | AUTOSOFT XC | UNO INSET I 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001681 | 6004986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male |