FDA Adverse Event
Malfunction
Summary report: N
UNO EWIS BLUE 60/9 HCAP 5-PACK CA
MDR report key: 19769733
·
Received July 18, 2024
Report
- Report Number
- 3003442380-2024-15048
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- June 16, 2024
- Report Date
- July 19, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1915804- MDR 3003442380-2024-15048- DEVICE 4 OF 4. E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED ISSUE WITH 4 INFUSION SETS ADHESIVE ON 16-JUN-2024. THE INFUSION SET CAME OFF. ONE SET FELL AS IT GOT WELL, WHILE ONE GOT CAUGHT OFF WHILE CLOSING THE DRAWER AND GOT DETACHED FROM STOMACH AND BLED. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144807 | UNO EWIS BLUE 60/9 HCAP 5-PACK CA | UNO EWIS BLUE 60/9 HCAP 5-PACK CA | FPA | UNOMEDICAL A/S | MMT-441AG | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |