FDA Adverse Event
Death
Summary report: N
MUGARD
MDR report key: 18757797
·
Received February 21, 2024
Report
- Report Number
- MW5151790
- Event Type
- Death
- Date Received
- February 21, 2024
- Report Date
- February 16, 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
PT PASSED AWAY (B)(6) 2024. FREQ: SWISH AND EXPEL OR SWALLOW 5 TO 10 ML, 4 TO 6 TIMES DAILY AS PRESCRIBED FOR THE MANAGEMENT OF ORAL MUCOSITIS. PRESCRIBER CONTACT INFO: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1576155 | MUGARD | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | MGQ | SOLEVA PHARMA LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death | AMLODIPINE TAB 2.5MG.| CYMBALTA CAP 30MG.| DOXYCYCL HYC TAB 100MG.| MULTIVITAMIN TAB MEN.| OXYCODONE TAB 5MG.| POT CHLORIDE TAB 8 MEQ ER .| VALACYCLOVIR TAB 500MG. |