Brand Name | J-PLASMA |
Type of Device | J-PLASMA |
Manufacturer (Section D) |
BOVIE MEDICAL CORPORATION |
5115 ulmerton road |
clearwater FL 33760 4004 |
|
Manufacturer Contact |
april
baures
|
5115 ulmerton road |
clearwater, FL 33760-4004
|
7273842323
|
|
MDR Report Key | 9238447 |
MDR Text Key | 192451771 |
Report Number | 3007593903-2019-00027 |
Device Sequence Number | 1 |
Product Code |
GEI
|
UDI-Device Identifier | 00607151009458 |
UDI-Public | 00607151009458 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112233 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
10/18/2019 |
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 |
Health Professional
|
Device Expiration Date | 08/01/2022 |
Device Model Number | J-PLASMA |
Device Catalogue Number | BVX-150B |
Device Lot Number | 0818J |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 10/08/2019 |
Initial Date Manufacturer Received |
09/26/2019
|
Initial Date FDA Received | 10/25/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/24/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|