FDA Adverse Event
Malfunction
Summary report: N
MERIT CUSTOM KIT
MDR report key: 1900196
·
Received October 23, 2010
Report
- Report Number
- 1721504-2010-00331
- Event Type
- Malfunction
- Date Received
- October 23, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 27, 2010
- Manufacturer
- MERIT MEDICAL SYSTEMS, INC.
- Product Code
- DTL
- PMA / PMN Number
- K934123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE DEVICE EVAL HAS NOT BEEN COMPLETED. EVAL CONCLUSIONS: A F/U REPORT WILL BE SUBMITTED WHEN THE DEVICE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE ROTATOR BROKE DURING LEFT VENTRICULOGRAPHY. NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MERIT CUSTOM KIT | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DTL | MERIT MEDICAL SYSTEMS, INC. | F596212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CONTRAST MEDIA |