MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-29 for KOTEX U-PADS REGULAR manufactured by .
[2566961]
I used u-pads by kotex that were sent to me by the company as a trial and now my skin is irritated and itching for three days already. I never had that problem before and this is the first time i used this kind of pads. The product was not damaged before the incident. The product was not notified before the incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023829 |
| MDR Report Key | 2421598 |
| Date Received | 2011-12-29 |
| Date of Report | 2011-12-04 |
| Date of Event | 2011-12-01 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOTEX U-PADS REGULAR |
| Generic Name | MENSTRUAL PAD |
| Product Code | HHL |
| Date Received | 2011-12-29 |
| Model Number | U-PADS |
| ID Number | MFR DATE: 07/01/2010 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-29 |