MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for EQUATE SUPER MAXI PADS manufactured by Unk.
[130313962]
Menstrual sanitary pads caused me to have mild/moderate vaginal chemical burns. They don't have an ingredients list so there's no way to tell what the irritant was. Dates of use: (b)(6) 2018. Diagnosis or reason for use: mild incontinence. Is the product over-the-counter? Yes; event abated after use stopped or dose reduced? Yes; event reappeared after reintroduction? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082065 |
| MDR Report Key | 8155415 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-10 |
| Date of Event | 2018-12-10 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 | EQUATE SUPER MAXI PADS |
| Generic Name | MENSTRUAL SANITARY PADS |
| Product Code | HHD |
| Date Received | 2018-12-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |