FDA Adverse Event
Other
Summary report: N
HYSEPT SOLUTION 473ML
MDR report key: 18474950
·
Received January 8, 2024
Report
- Report Number
- MW5149945
- Event Type
- Other
- Date Received
- January 8, 2024
- Manufacturer
- PATRIN PHARMA, INC.
- Product Code
- FRO
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
DAKIN'S SOLUTION QUARTER STRENGTH (BY CENTURY PHARMACEUTICALS) IS IN A BOTTLE THAT LOOKS LIKE BULK BOTTLES USED FOR ORAL SOLUTIONS. HOWEVER, IT IS FOR TOPICAL USE ONLY BUT THERE ARE NO WARNINGS. HYSEPT (BY PATRIN PHARMA) HAS A MUCH DIFFERENT SHAPE AND DIFFERENT SPOUT/TOP AND ALSO STATES "TOPICAL USE ONLY" ON THE LABEL. (B)(4) IS A FEDERALLY CERTIFIED PATIENT SAFETY ORGANIZATION AND AN FDA MEDWATCH PARTNER. (B)(4). REFERENCE REPORTS: MW5149943, MW5149944.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003090 | HYSEPT SOLUTION 473ML | DRESSING, WOUND, DRUG | FRO | PATRIN PHARMA, INC. | 39328-063-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |