Brand Name | KROGER |
Type of Device | ADVANCED ANTIBACTERIAL FLEXIBLE FABRIC BANDAGES ALL ONE SIZE |
Manufacturer (Section D) |
ASO AMERICAS, S. DE R. L. DE C. V. |
centro industrial juarez |
rio michigan, 9730 |
juarez, chihuahua 32648 |
MX 32648 |
|
Manufacturer (Section G) |
ASO LLC |
300 sarasota center blvd |
|
sarasota FL 34240 |
|
Manufacturer Contact |
aso complaints
|
300 sarasota center blvd. |
sarasota, FL 34240
|
|
MDR Report Key | 16162217 |
MDR Text Key | 307464173 |
Report Number | 1038758-2022-00054 |
Device Sequence Number | 1 |
Product Code |
KGX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/13/2023 |
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 |
Lay User/Patient
|
Device Model Number | UPC#041260384028 |
Device Lot Number | 00165229 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/21/2022 |
Initial Date FDA Received | 01/13/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/27/2022 |
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 |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
|
|