MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; GEL, ULTRASOUND, BOTTLE, 8.5-OZ, BLUE

Model Number	MDS092005
Health Effect - Clinical Code	Rash (2033)
Date of Event	06/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported by end user's mother that on (b)(6) 2020 her (b)(6)-year son was having an echocardiogram of his heart and shortly after the ultrasound gel (mds092005) was applied to his left upper chest, that entire area developed a rash.Mother described as red, raised, itchy pumps.End user was prescribed a steroid cream, and given 25 mg oral benadryl.Mother reports, the itching subsided shortly after her son took the benadryl and the red rash was "almost completely gone by that evening".Mother reports her son is allergic to several foods (peanuts, walnuts, nuts, just to name a few), and several environmental allergens.Reporter does not have the sample available for return.Therefore, a root cause cannot be determined.There is no further information at this time.Due to the reported medical intervention and in abundance of caution, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported, that the reporter's son had an ultrasound.After returning home, son took a bath and she noticed that he had a rash.

• Brand Name: MEDLINE
• Common Device Name: GEL, ULTRASOUND, BOTTLE, 8.5-OZ, BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10283465
• Report Number: 1417592-2020-00067
• Device Sequence Number: 10883904
• Product Code: ITX
• UDI-Device Identifier: 10080196166251
• UDI-Public: 10080196166251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: MDS092005
• Device Catalogue Number: MDS092005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 29