MalfunctionKYX
THE MEDI-DOSE GROUP STERI-DROPPER 7ML STERILE DROPPER BOTTLE
Received Dec 8, 2025 · Event occurred Dec 3, 2025
Report MW5180109 · MDR key 23744460
Device
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 01/08/2026 FOR REPORT MW5180109 TO REPLACE MFR. MEDI-DOSE, INC./ EPS, INC., 70 INDUSTRIAL DR, IVYLAND, PA 18974.
Description of Event or Problem
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.