FDA Adverse Event
Injury
Summary report: N
MUGARD ORALL RINSE 24 ML/BTL
MDR report key: 22440091
·
Received July 8, 2025
Report
- Report Number
- MW5172416
- Event Type
- Injury
- Date Received
- July 8, 2025
- Report Date
- July 2, 2025
- Manufacturer
- SOLEVA PHARMA LLC
- Product Code
- MGQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- N
Narratives
Description of Event or Problem · 0
PATIENTS BUSINESS PARTNER, (B)(6), REPORTED PATIENT IS IN THE HOSPITAL. FREQ: SWISH AND SWALLOW 5-10 MLS TWICE DAILY STARTING FIRST DAY OF RADIATION THERAPY. PRESCRIBER CONTACT INFORMATION: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148689 | MUGARD ORALL RINSE 24 ML/BTL | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | MGQ | SOLEVA PHARMA LLC | MV1040 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization | EZETIMIBE TAB 10MG.| MONTELUKAST SODIUM.| OMEPRAZOLE CAP 40 MG.| PREDNISONE TAB 20MG. |