FDA Adverse Event
Death
Summary report: N
MUGARD ORAL RINSE 240ML/BTL
MDR report key: 21057026
·
Received January 2, 2025
Report
- Report Number
- MW5164152
- Event Type
- Death
- Date Received
- January 2, 2025
- Report Date
- December 26, 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: THE PATIENT WAS MARKED DECEASED IN (B)(6) RETAIL SYSTEM WHICH FLOWED TO (B)(6) SPECIALTY SYSTEM, AND WE ARE REPORTING PER CONTRACTUAL REQUIREMENTS AND STANDARD OPERATING PROCEDURE WITHIN ONE BUSINESS DAY; HOWEVER, NO CAUSE OF DEATH KNOWN. DATE OF DEATH UNKNOWN AND NO FURTHER INFORMATION AVAILABLE. FREQ: SWISH AND SWALLOW 5ML AS DIRECTED 4-6 TIMES PER DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1911284 | MUGARD ORAL RINSE 240ML/BTL | DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC | MGQ | SOLEVA PHARMA LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Death |