MAUDE Adverse Event Report: COVIDIEN CARDINAL HEALTH ULTRASOUND GEL; MEDIA COUPLING ULTRASOUND

Catalog Number USG250BT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033)

Event Date 09/28/2018

Event Type  Injury  

Event Description

Had ultrasounds on (b)(6) and (b)(6) "2018", which resulted in rashes which spread over entire body - ultrasound gel product was cardinal health ultrasound gel.Have been treated with fluocinonide cream, desoximetasone cream, oral prednisone (all steroids) and tacrolimus ointment.Rash still persists and keeps spreading.Persistent painful, raw itchy rash resulted from product.Distributed by (b)(4).

• Brand Name: CARDINAL HEALTH ULTRASOUND GEL
• Type of Device: MEDIA COUPLING ULTRASOUND
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8436315
• MDR Text Key: 139421002
• Report Number: MW5085017
• Device Sequence Number: 1
• Product Code: MUI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/06/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: USG250BT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR