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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TORBOT GROUP, INC. SKIN TAX BARRIER WIPE COLLECTOR, OSTOMY

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TORBOT GROUP, INC. SKIN TAX BARRIER WIPE COLLECTOR, OSTOMY Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rash (2033); Blister (4537)
Event Date 11/01/2020
Event Type  Injury  
Event Description
My son has been using the dexcom cgm, g5 and now g6, for the last 2 plus years without any adverse side effects. Starting in november he started to develop very bad rashes with some blistering that required treatment with antibiotic cream. I made contact with dexcom and was advised that they had changed a binding agent in the adhesive and they provided me different things to try. We first tried skintac, barrier wipe. This did not work and the rash continued. We then tried tegaderm, barrier film. That also did not help with the rash. I spoke to dexcom again and they recommended that we try spraying flonase on the skin first and if that didn't work, we should use a thicker barrier film, duoderm. My son tried flonase alone and that did not help the rash. Finally, he is now trying the duoderm product. As a type 1 diabetic my son needs his cgm to appropriately monitor his blood sugar and the lows that can be life threatening. We are looking for assistance as he had no problem prior to the change by dexcom in their adhesive formula. Fda safety report id # (b)(4).
 
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Brand NameSKIN TAX BARRIER WIPE
Type of DeviceCOLLECTOR, OSTOMY
Manufacturer (Section D)
TORBOT GROUP, INC.
MDR Report Key11272783
MDR Text Key230532964
Report NumberMW5099181
Device Sequence Number4
Product Code EXB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/31/2021
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/02/2021 Patient Sequence Number: 1
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