MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-26 for TOTAL DRY manufactured by Secure Personal Care Products, Llc.
[137365811]
I bought feminine napkins, incontinence feminine napkins at local (b)(6) store. There is a burning chemical irritant smell that when applied to female genital area it burns, lingers even after taking it off and makes you sick. It also has an odor to it. When liquids or urine are added to it, it has a really bad, sickening smell to it unlike human smell. It compounds or doubles if not tripled the smell. The chemicals seems to make my legs hurt too. The chemicals are getting inside or are absorbed into my body. How was it taken or used? Vaginal. Therapy duration: 1 hour. Why was the person using the product? Bladder control protection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084403 |
| MDR Report Key | 8372016 |
| Date Received | 2019-02-26 |
| Date of Report | 2019-02-23 |
| Date of Event | 2019-02-22 |
| Date Added to Maude | 2019-02-26 |
| 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 | TOTAL DRY |
| Generic Name | GARMENT PROTECTIVE FOR INCONTINENCE |
| Product Code | EYQ |
| Date Received | 2019-02-26 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECURE PERSONAL CARE PRODUCTS, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-26 |