FDA Adverse Event
Malfunction
Summary report: N
GCI SHEATH/DILATOR
MDR report key: 2462020
·
Received February 14, 2012
Report
- Report Number
- 1625425-2012-00012
- Event Type
- Malfunction
- Date Received
- February 14, 2012
- Report Date
- January 26, 2012
- Manufacturer
- ARGON MEDICAL DEVICES INC.
- Product Code
- DRE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS OF DEVICE EVALUATION WILL BE FILED IN A SUPPLEMENTAL REPORT WHEN SAMPLE IS RECEIVED.
Description of Event or Problem · 1
THE SHEATH BROKE WHILE REMOVING FIBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GCI SHEATH/DILATOR | DILATOR | DRE | ARGON MEDICAL DEVICES INC. | NA | 99767690 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |