FDA Adverse Event
Malfunction
Summary report: N
MECC AVR
MDR report key: 4210831
·
Received August 1, 2014
Report
- Report Number
- 2248146-2014-00320
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Report Date
- June 10, 2011
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
PHYSICIAN MENTIONED TO TERRITORY MANAGER TODAY ((B)(6) 2011) THAT ON HIS (B)(6) PERFORMED ON MONDAY, (B)(6) 2011 THAT HE EXPERIENCED A VENTRICULAR CLOT WHICH HAD TO BE REMOVED AND MANAGED WITH ANTI-PLATELET THERAPY. DID NOT REPORT ANY ADVERSE PATIENT EVENT. EMAIL DATED (B)(6) 2011 FROM TERRITORY MANAGER INDICATES THIS HAPPENED ONCE BEFORE ON A (B)(6) BUT DID NOT HAVE A SPECIFIC DATE OR MORE DETAILS. THIS COMPLAINT IS FOR THE SECOND CASE THAT HAPPENED ONCE BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 452149 | MECC AVR | CARDIOPULMONARY DEVICE | DWE | DATASCOPE CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |