Brand Name | FLASH OSTIAL SYSTEM OTW |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
OSTIAL CORPORATION |
197 east hamilton ave |
suite 101 |
campbell CA 95008 |
|
MDR Report Key | 7669277 |
MDR Text Key | 113418270 |
Report Number | 7669277 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/29/2018,06/18/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | OTW6012BA |
Device Catalogue Number | OTW6012BA |
Device Lot Number | 180308-01 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/29/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 07/09/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 07/09/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 32485 DA |
Patient Weight | 75 |
|
|