Brand Name | CVS HEALTH |
Type of Device | NON-STICK PADS |
Manufacturer (Section D) |
SUZHOU INDUSTRIAL PARK VICON HYGIENIC MATERIAL CO. |
no.18, zhihe dong road |
suzhou industrial park |
suzhou, 21512 2 |
CH 215122 |
|
Manufacturer (Section G) |
ASO LLC |
300 sarasota center blvd. |
|
sarasota FL 34240 |
|
Manufacturer Contact |
federico
juliao
|
300 sarasota center blvd. |
sarasota, FL 34240
|
|
MDR Report Key | 9521093 |
MDR Text Key | 188562400 |
Report Number | 1038758-2019-00058 |
Device Sequence Number | 1 |
Product Code |
NAC
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/26/2019,11/25/2019 |
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 |
No Information
|
Device Model Number | UPC#050428307274 |
Device Catalogue Number | 935683 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Report to Manufacturer | 11/26/2019 |
Initial Date Manufacturer Received |
11/26/2019 |
Initial Date FDA Received | 12/26/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|