MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-09 for NATURE'S PLACE HYPOALLERGENIC WIPES SENSITIVE manufactured by Unk.
[82534117]
Purchased nature's place hypoallergenic sensitive wipes on (b)(6) 2017. I used them for three days and started breaking out in an itchy rash which very quickly spread. I initially thought perhaps i had been stung by an insect, but when it started spreading so quickly i went to my doctor. He gave me a prednisone shot and told me to take benadryl when i got home. After taking two benadryl at a time every 8 hours, i still kept breaking out. I finally realized my labia were horribly swollen and that is where the problem originated. When i stopped using the wipes,the condition cleared up. "is the product over-the-counter: yes, frequency: 4 times a day, how was it taken or used: topical, dates of use: (b)(6) 2017 - (b)(6) 2017, did the problem stop after the person reduced the dose or stopped taking or using the product: yes. Vaginal wipe after urination. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071490 |
| MDR Report Key | 6785234 |
| Date Received | 2017-08-09 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-07-31 |
| Date Added to Maude | 2017-08-10 |
| 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 | NATURE'S PLACE HYPOALLERGENIC WIPES SENSITIVE |
| Generic Name | FEMININE WIPE |
| Product Code | NEC |
| Date Received | 2017-08-09 |
| Lot Number | 160928MO |
| Device Expiration Date | 2019-04-01 |
| Device Availability | Y |
| 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 | 2017-08-09 |