FDA Adverse Event
Malfunction
Summary report: N
PERIMOUNT MAGNA EASE AORTIC SIZER
MDR report key: 1232293
·
Received November 5, 2008
Report
- Report Number
- 6000002-2008-09192
- Event Type
- Malfunction
- Date Received
- November 5, 2008
- Date of Event
- October 15, 2008
- Report Date
- October 15, 2008
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DTI
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS: OTHER: DEVICE EVALUATION ANTICIPATED, BUT NOT BEGUN.
Description of Event or Problem · 1
REPORTEDLY, ITEM RETURNED FROM FOOTHILLS HOSPITAL PER PHONE CONVERSATION WITH COMPANY REPRESENTATIVE. NO PT INFO, SIZER RETURNED CRACKED OR MISSING PIECES. UNK IF BEFORE OR DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERIMOUNT MAGNA EASE AORTIC SIZER | REPLACEMENT HEART VALVE SIZER | DTI | EDWARDS LIFESCIENCES | 1133 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |