MAUDE Adverse Event Report: DOMPE US INC. PIPETTE; DISPENSER, LIQUID MEDICATION

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Many pipettes don't work properly.She can pull it into the pipette, but if she doesn't hold the plunger out, the contents will be sucked back into the vial.Unk, first accredo, ship date: 06/28/2021.

• Brand Name: PIPETTE
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): DOMPE US INC.
• MDR Report Key: 15537151
• MDR Text Key: 301192062
• Report Number: MW5112401
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: DROPS DORZOLAMIDE 2%; ELIQUIS 2.5 MG TAB; METOPROLOL SUCCINATE; OXERVATE 0.002% OPTH DROPS 1 ML 7'S, MFR: DOMPE U.S. INC.: 71981-0020-07, LOT: 22C8736; PRED FORTE 1% DROPS SUSP; PREVASTATIN SODIUM 10 MG TAB; RESTASIS MULTIDOSE 0.05 %; VALACYCLOVIR 1000 MG TAB
• Patient Age: 75 YR
• Patient Sex: Female