Brand Name | ANALYZER SURGICAL CABLE |
Type of Device | PROGRAMMER, PACEMAKER |
Manufacturer (Section D) |
COV LP/LLC, AUGUSTA |
1647 perkins rd |
augusta GA 30913 |
|
Manufacturer (Section G) |
COV LP/LLC, AUGUSTA |
1647 perkins rd |
|
augusta GA 30913 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 10397520 |
MDR Text Key | 202988632 |
Report Number | 1018120-2020-00008 |
Device Sequence Number | 1 |
Product Code |
KRG
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | P890003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/12/2020 |
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 Model Number | 2292 |
Device Catalogue Number | 2292 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/13/2020 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/16/2020 |
Initial Date FDA Received | 08/12/2020 |
Date Device Manufactured | 02/18/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|