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

Catalog Number USG-250BT

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 09/28/2018

Event Type  Injury  

Event Description

Persistent painful, raw itchy rash resulted from product.Had ultrasounds on (b)(6) 2018 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.

• Brand Name: CARDINAL HEALTH ULTRASOUND GEL
• Type of Device: MEDIA, COUPLING, ULTRASOUND
• Manufacturer (Section D): CARDINAL HEALTH/COVIDIEN
• MDR Report Key: 8405795
• MDR Text Key: 138395371
• Report Number: MW5084788
• 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

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?: No
• Device Operator: No Information
• Device Catalogue Number: USG-250BT
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR