MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-10 for CAREFREE ACTI-FRESH PANTILINERS manufactured by Unknown.
[49514343]
I used carefree "acti-fresh" pantiliners for two days, which resulted in a severe vaginal mesh that consisted of serious swelling, a number of huge blisters and extremely painful urination (one blister seemed to block my urethral). At first, i did not know what the cause of my irritation was, so problems worsened until i was in excruciating pain and discomfort. Had i not figured out the source of my outbreak, i would have gone today to emergency room (today is sunday). As soon as i discontinued use of the product, symptoms started to improve (though 20 hours later i'm still a little sore and swollen). I am a (b)(6) woman who has been using sanitary products for decades. I have never had an outbreak like this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063348 |
| MDR Report Key | 5790073 |
| Date Received | 2016-07-10 |
| Date of Report | 2016-07-10 |
| Date of Event | 2016-07-09 |
| Date Added to Maude | 2016-07-13 |
| 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 | CAREFREE ACTI-FRESH PANTILINERS |
| Generic Name | CAREFREE ACTI-FRESH PANTILINERS |
| Product Code | HHL |
| Date Received | 2016-07-10 |
| Lot Number | 16018M5027 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | 16018M5027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2016-07-10 |