Brand Name | UNK_ACE BLADE ADVANCE CUTTING SYSTEM |
Type of Device | E-Z CLEAN ACE BLADE, MODIFIED, STERILE 4.0 |
Manufacturer (Section D) |
MEGADYNE MEDICAL PRODUCTS, INC. |
11506 south state street |
draper UT 84020 |
|
Manufacturer Contact |
kara
ditty-bovard
|
11506 south state street |
draper, UT 84020
|
6107428552
|
|
MDR Report Key | 9572360 |
MDR Text Key | 176035956 |
Report Number | 1721194-2020-00005 |
Device Sequence Number | 1 |
Product Code |
GEI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/14/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNK_ACE BLADE ADVANCE CUTTING |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
12/14/2019
|
Initial Date FDA Received | 01/09/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|