FDA Adverse Event
Malfunction
Summary report: N
THE MEDI-DOSE GROUP STERI-DROPPER 7ML STERILE DROPPER BOTTLE
MDR report key: 23744460
·
Received December 8, 2025
Report
- Report Number
- MW5180109
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- December 3, 2025
- Report Date
- December 3, 2025
- Manufacturer
- MEDI-DOSE, INC./ EPS, INC.
- Product Code
- KYX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AR, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
STERI-DROPPER BOTTLE HAD AN EYELASH IN ONE SEALED CONTAINER AND FOREIGN MATERIAL INSIDE ONE OF THE BOTTLES. SAME LOT NUMBER ON TWO SEPARATE CONTAINERS. PT CODE: 4580. DEVICE CODE: 1120. REF REPORT: MW5180108.
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 01/08/2026 FOR REPORT MW5180109 TO REPLACE MFR. MEDI-DOSE, INC./ EPS, INC., 70 INDUSTRIAL DR, IVYLAND, PA 18974.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2796528 | THE MEDI-DOSE GROUP STERI-DROPPER 7ML STERILE DROPPER BOTTLE | DISPENSER, LIQUID MEDICATION | KYX | MEDI-DOSE, INC./ EPS, INC. | P223294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |