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U.S. Department of Health and Human Services

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

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MEDLINE INDUSTRIES INC. MEDLINE GEL, ULTRASOUND, BOTTLE, 8.5-OZ, BLUE Back to Search Results
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.
 
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Brand NameMEDLINE
Type of DeviceGEL, 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 Key10283465
MDR Text Key202586073
Report Number1417592-2020-00067
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMDS092005
Device Catalogue NumberMDS092005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/16/2020 Patient Sequence Number: 1
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