MAUDE Adverse Event Report: ECO-MED PHARMACEUTICALS, INC. RED MEDICAL SUPPLIES ULTRASOUND GEL; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Lot Number B072

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 08/02/2021

Event Type  Injury  

Event Description

Rash and itching.Use of otc meds.Fda safety report id# (b)(4).

• Brand Name: RED MEDICAL SUPPLIES ULTRASOUND GEL
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): ECO-MED PHARMACEUTICALS, INC.
• MDR Report Key: 12306946
• MDR Text Key: 266206175
• Report Number: MW5103139
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: B072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 37 YR
• Patient Weight: 77