FDA Adverse Event
Injury
Summary report: N
MUGARD ORAL RINSE 240 ML/BTL
MDR report key: 19744099
·
Received July 12, 2024
Report
- Report Number
- MW5157264
- Event Type
- Injury
- Date Received
- July 12, 2024
- Report Date
- July 10, 2024
- Manufacturer
- SOLEVA PHARMA LLC
- Product Code
- MGQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EVENT: PATIENT STATES HE NOW HAS LIVER CANCER. FREQ: SWITCH AND EXPEL OR SWALLOW 5-10 ML 4-6 TIMES DAILY AS PRESCRIBED FOR THE MANAGEMENT OF ORAL MUCOSITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738553 | MUGARD ORAL RINSE 240 ML/BTL | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | MGQ | SOLEVA PHARMA LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other | CEPHALEXIN | DOXYCYCLINE POW MONOHYDR| ELIQUIS TAB 5MG| HYDROCOD / IBU TAB 7.5-200| ONDANSETRON TAB 4MG| PROTONIX TAB 20MG |