FDA Adverse Event
Malfunction
Summary report: N
INSET
MDR report key: 20058200
·
Received August 24, 2024
Report
- Report Number
- 3003442380-2024-22558
- Event Type
- Malfunction
- Date Received
- August 24, 2024
- Date of Event
- July 25, 2024
- Report Date
- November 1, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244025202
- 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 1950974 - MDR 3003442380-2024-22558 - DEVICE 5 OF 8.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED EIGHT INFUSION SET INSERTION WITHOUT REMOVING THE NEEDLE EVENT ON 25-JUL-2024 DUE TO WHICH THE PATIENT WAS HAVING ADHESIVE ISSUES. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1193851 | INSET | UNO INSET I 60/6 GREY BETA 10PK INT | FPA | UNOMEDICAL A/S | FG000016-01 | 6004912 | 05705244025202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |