MAUDE Adverse Event Report: PARKER LABORATORIES INC AQUASONIC 100; MEDIA,COUPLING,ULTRASOUND

Model Number ULTRASOUND TRANSMISSION GEL

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Date 08/16/2021

Event Type  malfunction  

Event Description

Aquasonic 100 ultrasound transmission gel - according to the joint commission "since there is no effective way to determine whether an opened bottle of gel has been contaminated, general guidelines are that the gel should be marked to expire 28 days after opening.Using a warmer for the gel does not impact the expiration time." our request is for the manufacturer to have an area on the gel bottle /container where the user can record the expiration date.This would improve patient safety and assist with compliance of recording expiration date.

• Brand Name: AQUASONIC 100
• Type of Device: MEDIA,COUPLING,ULTRASOUND
• Manufacturer (Section D): PARKER LABORATORIES INC; 286 eldridge rd; fairfield NJ 07004
• MDR Report Key: 12369921
• MDR Text Key: 268233071
• Report Number: 12369921
• Device Sequence Number: 1
• Product Code: MUI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ULTRASOUND TRANSMISSION GEL
• Device Catalogue Number: 01-08
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2021
• Date Report to Manufacturer: 08/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1