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

Model Number MDS092005

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

Patient Problem Rash (2033)

Event Date 06/30/2020

Event Type  Injury  

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 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
• Type of Device: GEL, ULTRASOUND, BOTTLE, 8.5-OZ, BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 9311514
• MDR Report Key: 10283465
• MDR Text Key: 202586073
• Report Number: 1417592-2020-00067
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 10080196166251
• UDI-Public: 10080196166251
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDS092005
• Device Catalogue Number: MDS092005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 29