MAUDE Adverse Event Report: CONVATEC INC. OSTOMY APPLIANCE BELT 42"; COLLECTOR, OSTOMY

Model Number 175507

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 03/27/2013

Event Type  Injury  

Manufacturer Narrative

Convatec is submitting this report as a result of activities related to (b)(4).Convatec is submitting this report pursuant to the provisions of 21cfr part 803.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

End user reports he developed superficial skin loss with bleeding beneath the connection of the belt and the belt loops.The end user reported the area developed about 1-2 weeks ago.The end user went to a wound clinic and saw an ostomy nurse.The area is being treated with aquacel ag and a cover dressing.He has not seen it since the dressing was applied.The end-user was scheduled for a follow up visit.

• Brand Name: OSTOMY APPLIANCE BELT 42"
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5288639
• MDR Text Key: 33263869
• Report Number: 1049092-2015-40096
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/06/2015

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: No Information
• Device Model Number: 175507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: METOPROLOL
• Patient Weight: 118