FDA Adverse Event
Injury
Summary report: N
SAPPHIRE M.T INFUSION PUMP - FRENCH
MDR report key: 13018471
·
Received December 16, 2021
Report
- Report Number
- 3010293992-2021-00065
- Event Type
- Injury
- Date Received
- December 16, 2021
- Date of Event
- December 3, 2021
- Report Date
- March 16, 2022
- Manufacturer
- EITAN MEDICAL LTD
- Product Code
- FRN
- PMA / PMN Number
- K192860
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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).
Description of Event or Problem · 0
THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6). 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 |
|---|---|---|---|---|---|---|---|
| 1919480 | SAPPHIRE M.T INFUSION PUMP - FRENCH | INFUSION PUMP | FRN | EITAN MEDICAL LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |