FDA Adverse Event
Malfunction
Summary report: N
QUADRA COIL
MDR report key: 1546960
·
Received November 20, 2009
Report
- Report Number
- 1546960
- Event Type
- Malfunction
- Date Received
- November 20, 2009
- Date of Event
- November 12, 2009
- Report Date
- November 20, 2009
- Manufacturer
- GYRUS ACMI
- Product Code
- FAD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
Narratives
Description of Event or Problem · 1
GYRUS ACMI URETERAL STENT, REF 5001945, QUADRA COIL, 4.5 X 22-28 CM, LOT MBS A980, EXP DATE 2014-03. THE DR. WAS UNABLE TO SEE THE CATHETER IN THE KIDNEY, COULD NOT VERIFY POSITION, AND WAS UNABLE TO SEE UPON X-RAY. THE PRODUCT WAS REMOVED, AND A DIFFERENT PRODUCT WAS USED. THE PRODUCT IS HERE ON TRIAL.
Description of Event or Problem · 1
GYRUS ACMI URETERAL STENT, REF 5001945, QUADRA COIL, 4.5 X 22-28 CM, LOT MBS A980, EXP DATE 2014-03. THE DR. WAS UNABLE TO SEE THE CATHETER IN THE KIDNEY, COULD NOT VERIFY POSITION, AND WAS UNABLE TO SEE UPON X-RAY. THE PRODUCT WAS REMOVED, AND A DIFFERENT PRODUCT WAS USED. THE PRODUCT IS HERE ON TRIAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUADRA COIL | STENT, URETERAL | FAD | GYRUS ACMI | * | MSB A980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |