MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for INFINITY REGULAR UNSCENTED PAD WITH WINGS manufactured by Always.
[6257899]
I used always unscented infinity regular pads with wings that i bought at (b)(6). I used one from this new package and had a severe skin reaction to the product. The skin on my labia and buttocks became red, raised, and inflamed. The area became very itchy and my skin started coming off. I had changed the pad three times that day, and doing so did not alleviate any symptom. I returned the product and went to whole foods to purchase 100% organic cotton pads and tampons to try to minimize further irritation. The pain and itchiness stopped with this change. The entire first layer of my skin is gone and raw, and i have a rash that extends to my buttocks where the pad touched my skin. The swelling is gone but the skin is peeling off. The ingredients and parts of pads should be regulated to avoid dangerous reactions. My research into the issue indicates that other women have had issues with this product injuring their genitals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044790 |
| MDR Report Key | 4945839 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-20 |
| Date Added to Maude | 2015-07-29 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 | INFINITY REGULAR UNSCENTED PAD WITH WINGS |
| Generic Name | INFINITY REGULAR UNSCENTED PAD WITH WINGS |
| Product Code | HHD |
| Date Received | 2015-07-21 |
| Operator | LAY USER/PATIENT |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALWAYS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-21 |