FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 1677125
·
Received May 7, 2010
Report
- Report Number
- 1056128-2010-00014
- Event Type
- Malfunction
- Date Received
- May 7, 2010
- Date of Event
- April 12, 2010
- Report Date
- July 15, 2010
- Manufacturer
- ASCENT HALTHCARE SOLUTIONS
- Product Code
- NMF
- PMA / PMN Number
- K011832
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS TESTED BEFORE THE SURGERY AND WAS FOUND TO BE LEAKING. THE DEVICE WAS NOT USED ON THE PATIENT AND NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | N/A | NMF | NMF | ASCENT HALTHCARE SOLUTIONS | 11165 | 880274 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |