FDA Adverse Event
Malfunction
Summary report: N
NEXPOWDER
MDR report key: 20993418
·
Received December 19, 2024
Report
- Report Number
- MW5163800
- Event Type
- Malfunction
- Date Received
- December 19, 2024
- Date of Event
- December 5, 2024
- Report Date
- December 17, 2024
- Manufacturer
- NEXTBIOMEDICAL CO., LTD
- Product Code
- QAU
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WE HAD 2 BLEEDING VESSELS IN ESOPHAGUS THAT WE ATTEMPTED TO SPRAY WITH THE NEX POWDER IT DID NOT WORK THE POWDER WOULD NOT MOVE DOWN THE TUBE SO WE REMOVED IT FROM THE SCOPE AND USED HEMOSPRAY AND THAT WAS SUCCESSFUL. THE REP FOR MEDTRONIC CAME ON 12/6/2024 TO GIVE US MORE INFORMATION AND CONFIRMED WE DID EVERYTHING CORRECTLY AND IT WAS PROBLEM WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2627837 | NEXPOWDER | HEMOSTATIC DEVICE FOR ENDOSCOPIC GASTROINTESTINAL USE | QAU | NEXTBIOMEDICAL CO., LTD | H24041901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female |