FDA Adverse Event
Injury
Summary report: N
SAPPHIRE MT INFUSION PUMP - FRENCH
MDR report key: 14712058
·
Received June 16, 2022
Report
- Report Number
- 3010293992-2022-00009
- Event Type
- Injury
- Date Received
- June 16, 2022
- Date of Event
- April 26, 2022
- Report Date
- July 20, 2022
- Manufacturer
- EITAN MEDICAL LTD.
- Product Code
- FRN
- UDI-DI
- 00729010915071
- PMA / PMN Number
- K192860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
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).
Additional Manufacturer Narrative · 0
EITAN MEDICAL LTD IS FORMERLY NAMED Q CORE MEDICAL LTD. THE FEI NUMBER IS THE SAME: 3010293992.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2209942 | SAPPHIRE MT INFUSION PUMP - FRENCH | INFUSION PUMP | FRN | EITAN MEDICAL LTD. | 00729010915071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |