MAUDE Adverse Event Report: MEDLINE ULTRASOUND GEL - BOTH 5L AND 8.5OZ BOTTLES; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2021

Event Type  malfunction  

Event Description

I received a notice to stop using all ecomed brand of ultrasound gel.They also provided a list of other brands to discontinue, the medline brand of ultrasound gel was on the list.Ultrasound gel ¿ 5l, lot number ug15020921; 8.5 oz bottles, lot numbers ug05090120 and ug24120220.Fda safety report id# (b)(4).

• Brand Name: ULTRASOUND GEL - BOTH 5L AND 8.5OZ BOTTLES
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 12370229
• MDR Text Key: 268471402
• Report Number: MW5103502
• Device Sequence Number: 3
• Product Code: ITX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 08/23/2021
• 3 Devices were Involved in the Event: 1 2 3

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1