| Brand Name | TampaxTamponsPearlFullSizeSuperUnScnt50CT |
|---|
| Common Device Name | Tampon, Menstrual, Unscented - HEB |
|---|
| 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 | 50879523 |
|---|
| Report Number | 1219109-2026-00260 |
|---|
| Device Sequence Number | 10754929 |
|---|
| Product Code |
HEB
|
| UDI-Device Identifier | 00073010009226 |
|---|
| UDI-Public | (01)00073010009226 |
|---|
| Combination Product (Y/N) | N |
|---|
| Initial Reporter Country | US |
|---|
| PMA/510(K) Number | K081555 |
|---|
| Number of Events Summarized | 1 |
|---|
| Summary Report (Y/N) | N |
|---|
| Reporter Type |
Manufacturer
|
|---|
| Report Source |
Consumer |
|---|
| Type of Report
| Initial |
|---|
| Report Date (Section B) |
09/22/2026 |
|---|
| 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? |
Yes
|
|---|
| Operator of Device |
Lay User/Patient
|
|---|
| Device Lot Number | 6164243017 68 23:00 |
|---|
| Was Device Available for Evaluation? |
Yes
|
|---|
| Is the Reporter a Health Professional? |
No
|
|---|
| Initial Date Received by Manufacturer | 09/07/2026 |
|---|
| Initial Report FDA Received Date | 09/24/2026 |
|---|
| Was Device Evaluated by Manufacturer? (Y/N) |
Device Not Returned to Manufacturer
|
|---|
| Is the Device Labeled for Single Use? (Y/N) |
Yes
|
|---|
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N) |
No
|
|---|
| Usage of Device |
Unknown
|
|---|
| Patient Sequence Number | 1 |
|---|
| Patient Age | 41 YR |
|---|
| Patient Sex | Female |
|---|
