FDA Adverse Event
Other
Summary report: N
DIRECT DRIVE LCA
MDR report key: 1200390
·
Received October 15, 2008
Report
- Report Number
- 2027111-2008-00051
- Event Type
- Other
- Date Received
- October 15, 2008
- Date of Event
- September 15, 2008
- Report Date
- October 15, 2008
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED DEVICES FUNCTIONED PROPERLY AND CONFORMED TO ALL DESIGN SPECIFICATIONS. THE EXACT CAUSE OF THE FAILURE IS UNKNOWN. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT FOUND ALL DOCUMENTATION AND QUALITY CONTROL WITHIN DESIGN SPECIFICATIONS. THIS CONCLUDES OUR INVESTIGATION AND THE FILE IS NOW CLOSED. THIS DOCUMENT SERVES AS OUR FINAL REPORT.
Description of Event or Problem · 1
"CLIPS FELL OUT, APPLIER DID NOT "CLICK" AND "CLOSE", CLIPS TWISTED AND REMOVED FROM PATIENT. DID NOT SEAL END TO END."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE LCA | NONE | GDO | APPLIED MEDICAL RESOURCES | CA090 | 1066462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |