FDA Adverse Event
Injury
Summary report: N
SOCLEAN 2
MDR report key: 12814772
·
Received November 12, 2021
Report
- Report Number
- MW5105325
- Event Type
- Injury
- Date Received
- November 12, 2021
- Date of Event
- November 10, 2021
- Report Date
- November 10, 2021
- Manufacturer
- SOCLEAN, INC.
- Product Code
- LRJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
THE SO-CLEAN MACHINE MAKES ME FEEL AWFUL - SO EXTREMELY SICK AS IF I HAVE TO THROW UP. JDI ELECTRONICS FACTORY. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1699871 | SOCLEAN 2 | DISINFECTANT, MEDICAL DEVICES | LRJ | SOCLEAN, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Other |