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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYMED OSTOMY POUCH

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CYMED OSTOMY POUCH Back to Search Results
Model Number 86300W
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Rash (2033)
Event Date 02/01/2018
Event Type  No Answer Provided  
Event Description
Cymed 86300w ostomy bay causing skin rash under adhesive. They sent me 2 samples of this product. They both caused the same reaction. I waited about a month or longer between trial. Long enough to let my skin heal. (b)(4).
 
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Brand NameOSTOMY POUCH
Type of DeviceOSTOMY POUCH
Manufacturer (Section D)
CYMED
MDR Report Key7323210
MDR Text Key102075317
Report NumberMW5075750
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number86300W
Was Device Available for Evaluation? No
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

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