Brand Name | GOODWOOD MEDICAL CARELTD |
Type of Device | NASOPHARYNGEAL SWAB |
Manufacturer (Section D) |
GOODWOOD MEDICAL CARE LTD |
1-2floor, 3-919 jiulicun |
yongzheng street, jinzhou dist |
dalian, liaoning 11610 0 |
CH 116100 |
|
MDR Report Key | 10549167 |
MDR Text Key | 207734287 |
Report Number | 1924669-2020-00004 |
Device Sequence Number | 1 |
Product Code |
KXG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/17/2020 |
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 Expiration Date | 05/31/2023 |
Device Catalogue Number | GW-1237NP |
Device Lot Number | 20200508 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/17/2020 |
Distributor Facility Aware Date | 07/31/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/06/2020 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/17/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|