FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 20094049
·
Received August 29, 2024
Report
- Report Number
- 3003442380-2024-22905
- 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 - 22905 - DEVICE 1 OF 5.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON 22-JUL-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 |
|---|---|---|---|---|---|---|---|
| 1293886 | 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 |