MAUDE Adverse Event Report: CYMED OSTOMY POUCH

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).

• Brand Name: OSTOMY POUCH
• Type of Device: OSTOMY POUCH
• Manufacturer (Section D): CYMED
• MDR Report Key: 7323210
• MDR Text Key: 102075317
• Report Number: MW5075750
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 86300W
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 97