FDA Adverse Event
Injury
Summary report: N
TOTAL DRY
MDR report key: 8372016
·
Received February 26, 2019
Report
- Report Number
- MW5084403
- Event Type
- Injury
- Date Received
- February 26, 2019
- Date of Event
- February 22, 2019
- Report Date
- February 23, 2019
- Manufacturer
- SECURE PERSONAL CARE PRODUCTS, LLC
- Product Code
- EYQ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165484 | TOTAL DRY | GARMENT PROTECTIVE FOR INCONTINENCE | EYQ | SECURE PERSONAL CARE PRODUCTS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Other |