FDA Adverse Event
Other
Summary report: N
EASYPUMP
MDR report key: 1943835
·
Received December 21, 2010
Report
- Report Number
- 2026095-2010-00318
- Event Type
- Other
- Date Received
- December 21, 2010
- Date of Event
- October 16, 2010
- Report Date
- December 1, 2010
- Manufacturer
- I-FLOW CORP.
- Product Code
- MEB
- PMA / PMN Number
- K052117
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. THE SAMPLE WILL BE EVALUATED WHEN RECEIVED, AND A FOLLOW-UP REPORT WILL BE FILED.
Description of Event or Problem · 1
FAST FLOW. INFUSED IN 10-12 HOURS INSTEAD OF 24 HOURS. NO ADVERSE EVENT OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYPUMP | ELASTOMERIC PUMP | MEB | I-FLOW CORP. | LT-270-24 | 042754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |