Brand Name | PREMIERPRO PLUS |
Type of Device | POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE |
Manufacturer (Section D) |
SVS LLC |
14120 ballantyne corporate place, suite 425 |
charlotte NC 28277 |
|
MDR Report Key | 8926207 |
MDR Text Key | 155373557 |
Report Number | 8926207 |
Device Sequence Number | 1 |
Product Code |
LZC
|
UDI-Device Identifier | 00818566011022 |
UDI-Public | (01)00818566011022 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/01/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/23/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 5063 |
Device Catalogue Number | 5063 |
Device Lot Number | MTH12-16 |
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 | 08/01/2019 |
Event Location |
Other
|
Date Report to Manufacturer | 08/23/2019 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|