Brand Name | U BY KOTEX CLICK : TAMPON, MENSTRUAL, UNSCENTED : HEB |
Type of Device | TAMPON, MENSTRUAL, UNSCENTED |
Manufacturer (Section D) |
K-C AFC MANUFACTURING, S. DE R.L. DE C.V |
calzada industrial de las maquiladoras #87 |
nuevo nogales |
nogales, sonora mexico 84094 |
MX 84094 |
|
Manufacturer (Section G) |
K-C AFC MANUFACTURING, S. DE R.L. DE C.V |
calzada industrial de las maquiladoras #87 |
nuevo nogales |
nogales, sonora mexico 84094 |
MX
84094
|
|
Manufacturer Contact |
emily
arnould, rn bsn
|
2100 winchester rd |
neenah, WI 54956
|
9207213128
|
|
MDR Report Key | 19031223 |
MDR Text Key | 340111254 |
Report Number | 3011109575-2024-00031 |
Device Sequence Number | 1 |
Product Code |
HEB
|
UDI-Device Identifier | 00036000515862 |
UDI-Public | 00036000515862 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K172118 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/03/2024 |
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 |
Lay User/Patient
|
Device Model Number | REGULAR |
Device Lot Number | NN228313A |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/07/2024
|
Initial Date FDA Received | 04/03/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/10/2022 |
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 Sex | Female |
|
|