MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-04 for TAMPAX PEARL SUPER PLUS SCENTED TAMPONS manufactured by Unknown.
[96694275]
Tampax pearl super plus scented tampons gave me a recurrent yeast infection after use. After i researched it online, it is well known that scented tampons lead to bacterial vaginosis or yeast infections. Such products should not be on the market as yeast infections are embarrassing, anxiety inducing, and stressful to deal with while living a professional life. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: yes. Do you still have the product in case we need to evaluate it: yes. Why was the person using the product: menstruation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074419 |
| MDR Report Key | 7168598 |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-24 |
| Date Added to Maude | 2018-01-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TAMPAX PEARL SUPER PLUS SCENTED TAMPONS |
| Generic Name | TAMPAX PEARL SUPER PLUS SCENTED TAMPONS |
| Product Code | HIL |
| Date Received | 2018-01-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Brand Name | TAMPAX PEARL SUPER PLUS SCENTED TAMPONS |
| Generic Name | TAMPAX PEARL SUPER PLUS SCENTED TAMPONS |
| Product Code | HIL |
| Date Received | 2018-01-04 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TAMPAX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |