FDA Adverse Event
Injury
Summary report: N
SAPPHIRE M.T INFUSION PUMP- US
MDR report key: 12518079
·
Received September 23, 2021
Report
- Report Number
- 3010293992-2021-00054
- Event Type
- Injury
- Date Received
- September 23, 2021
- Report Date
- April 13, 2021
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 07290109150109
- PMA / PMN Number
- K192860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME: (B)(4).
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME (B)(4).
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. UNKNOWN ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: UNKNOWN ISSUE.
Description of Event or Problem · 1
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA: UNKNOWN ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417436 | SAPPHIRE M.T INFUSION PUMP- US | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 07290109150109 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening |