MAUDE Adverse Event Report: EUROMED INC CVS HYDROCOLLOID 2.3" X 3" - 4CT; HYDROCOLLOID BANDAGES

Model Number UPC 5042839793

Device Problems Failure to Obtain Sample (2533); Insufficient Information (3190)

Patient Problem Skin Discoloration (2074)

Event Date 06/01/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 - the end user reported that she has been using the device for bed sores; her skin is turning dark purple around the pad.

Manufacturer Narrative

No other similar complaints received.Pending response from consumer.

• Brand Name: CVS HYDROCOLLOID 2.3" X 3" - 4CT
• Type of Device: HYDROCOLLOID BANDAGES
• Manufacturer (Section D): EUROMED INC; orangeburg NY
• Manufacturer Contact: 300 sarasota center blvd.; sarasota, FL 34240 ; 9413790300
• MDR Report Key: 4894178
• MDR Text Key: 6070623
• Report Number: 1038758-2015-00042
• Device Sequence Number: 1
• Product Code: KGX
• 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,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UPC 5042839793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2015
• Initial Date FDA Received: 07/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1