FDA Adverse Event
Death
Summary report: N
ORAL WOUND DRESSING
MDR report key: 21854042
·
Received April 17, 2025
Report
- Report Number
- MW5169243
- Event Type
- Death
- Date Received
- April 17, 2025
- Report Date
- April 11, 2025
- Manufacturer
- SOLEVA PHARMA LLC.
- Product Code
- OLR
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- N
Narratives
Description of Event or Problem · 0
THE PT WAS MARKED DECEASED IN WALGREENS RETAIL SYSTEM WHICH FLOWED TO WALGREENS 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 UNK AND NO FURTHER INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813197 | ORAL WOUND DRESSING | ORAL WOUND DRESSING | OLR | SOLEVA PHARMA LLC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Death |