FDA Adverse Event
Malfunction
Summary report: N
DORMIA HELICAL STONE EXTRACTOR CH2.5, 120CM
MDR report key: 1914749
·
Received December 3, 2010
Report
- Report Number
- 9610711-2010-00004
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Report Date
- October 11, 2010
- Manufacturer
- COLOPLAST A/S
- Product Code
- FFL
- PMA / PMN Number
- K900269
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TWO SAMPLES IN A STERILIZED POUCH WERE RECEIVED FOR EXAMINATION. VISUAL EXAMINATION SHOWS THAT ONE DEVICE HAD ITS WIRE BROKEN AT THE HANDLE AS DESCRIBED. THE OTHER DEVICE HAS ITS CLOSED BASKET COMING OUT OF ITS SHEATH WHICH SEEMED TO BE TORN 15MM FROM ITS DISTAL TIP. THE COMPLAINT IS CONFIRMED AS REPORTED. REVIEW OF LOT HISTORY RECORDS INDICATES NO (B)(4) OR ANOMALIES RECORDED FOR THIS LOT NUMBER. TO DATE, THERE HAVE BEEN NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DORMIA HELICAL STONE EXTRACTOR CH2.5, 120CM | STONE EXTRACTOR | FFL | COLOPLAST A/S | DOR6341002 | 9040552 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |