Brand Name | GLIDERITE RIGID STYLET |
Type of Device | RIGID ENDOTRACHEAL STYLET |
Manufacturer (Section D) |
VERATHON MEDICAL ULC |
burnaby, ca-bc |
CA |
|
Manufacturer (Section G) |
VERATHON INCORPORATED |
21222 30th drive se, ste. 120 |
|
bothell WA 98021 701 |
|
Manufacturer Contact |
|
21222 30th drive se, ste. 120 |
bothell, WA 98021-7012
|
|
MDR Report Key | 3804373 |
MDR Text Key | 21725378 |
Report Number | 3022472-2014-00015 |
Device Sequence Number | 1 |
Product Code |
BSR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Source Type |
Unknown |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/24/2014,03/25/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 0270-0681/0803-0009 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 04/24/2014 |
Distributor Facility Aware Date | 03/25/2014 |
Event Location |
Outpatient Treatment Facility
|
Date Report to Manufacturer | 03/25/2014 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/24/2014 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|