Brand Name | TAMPAXTAMPONSCOMPAKCOMPAKSUPER |
Type of Device | TAMPON, MENSTRUAL, SCENTED - HIL |
Manufacturer (Section D) |
TAMBRANDS MANUFACTURING, INC |
2879 hotel rd |
auburn 04210 |
|
Manufacturer (Section G) |
TAMBRANDS MANUFACTURING, INC |
2879 hotel rd |
|
auburn 04210 |
|
Manufacturer Contact |
manager
affairs,feminine care
|
winton hill business center
b |
6280 center hill avenue |
cincinnati 45224
|
|
MDR Report Key | 17987571 |
MDR Text Key | 326300301 |
Report Number | 1219109-2023-00348 |
Device Sequence Number | 1 |
Product Code |
HEB
|
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K081555 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/03/2023 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 10/23/2023 |
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 Sex | Female |