FDA Adverse Event
Malfunction
Summary report: N
TRUFIT CB PLUG PURPLE, 11MM
MDR report key: 1549067
·
Received November 12, 2009
Report
- Report Number
- 1219602-2009-00284
- Event Type
- Malfunction
- Date Received
- November 12, 2009
- Date of Event
- November 3, 2008
- Report Date
- April 15, 2009
- Manufacturer
- MANSFIELD
- Product Code
- MQV
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVAL. (B) (4). (B) (4).
Description of Event or Problem · 1
PT PRESENTED BACK TO CLINIC WITH MILD EFFUSION BY 2 WEEKS FOLLOW-UP. PUNCTURE WAS PERFORMED ON (B) (6) 2008, 45 ML FLUID WAS DRAINED. THE ADVERSE EVENT GRADUALLY RESOLVED BY THE 6 WEEK FOLLOW-UP (B) (6) 2008. THE DOCTOR BELIEVES THE ADVERSE EVENT IS DEFINITELY RELATED TO THE PROCEDURE AND DEFINITELY RELATED TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT CB PLUG PURPLE, 11MM | TRUFIT CB PLUT PURPLE, 11MM/MQV | MQV | MANSFIELD | 72200936 | 50239572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |