Brand Name | ULTRAVAC |
Type of Device | APPARATUS, EXHAUST, SURGICAL |
Manufacturer (Section D) |
MEGADYNE MEDICAL PRODUCTS, INC. |
11506 s state st |
draper UT 84020 |
|
MDR Report Key | 8703775 |
MDR Text Key | 148199633 |
Report Number | 8703775 |
Device Sequence Number | 1 |
Product Code |
FYD
|
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 |
05/21/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 2110-10EC |
Device Lot Number | 7270 |
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 | 05/21/2019 |
Event Location |
Ambulatory Surgical Facility
|
Date Report to Manufacturer | 06/17/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/17/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 13140 DA |
|
|