MAUDE Adverse Event Report: TESTOSTERONE GEL PUMP 1.62%; DISPENSER, LIQUID MEDICATION

Lot Number 116862

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Pump will not dispense medication.

• Brand Name: TESTOSTERONE GEL PUMP 1.62%
• Type of Device: DISPENSER, LIQUID MEDICATION
• MDR Report Key: 12852630
• MDR Text Key: 281196386
• Report Number: MW5105503
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 43598030488
• UDI-Public: 43598030488
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 116862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male