MAUDE Adverse Event Report: CONVATEC INC. ESTEEM 1 PC CLOSED END POUCH - APS; POUCH, COLOSTOMY

Model Number 416715

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

Patient Problem Skin Discoloration (2074)

Event Date 08/15/2014

Event Type  Injury  

Event Description

It is reported the end user developed redness under portion of the one piece closed end pouch mass.End user reports going to the emergency room on (b)(6) 2014 due to the redness and was given tramadol 50mg tablets for pain.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.End user reports using the closed end device for 8 days with daily changing.She had used modified stomahesive mass previously without redness.She also reports using smith and nephew protectant wipe in combination, and uses just water to rinse skin.She reports pain was a 3 on a scale of 1-10 reports peristomal area was cleansed but no ointment or cream applied.No other prescription or over the counter medications were provided.She reports emergency room md thought it might be allergic reaction.She reports redness is better today and no pain currently.Reports had migraine headache last evening also.Reports she was instructed by emergency room to go back to her drainable convatec pouch.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ESTEEM 1 PC CLOSED END POUCH - APS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4098094
• MDR Text Key: 20857620
• Report Number: 9618003-2014-00081
• Device Sequence Number: 1
• Product Code: EZQ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/15/2014

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: 416715
• Device Catalogue Number: 416715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/03/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 49