MAUDE Adverse Event Report: CONVATEC INC. ESTEEM® + MOLDABLE ONE-PIECE CLOSED POUCH; POUCH, COLOSTOMY

Model Number 413510

Device Problem Difficult to Remove (1528)

Patient Problem Skin Irritation (2076)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).Device not returned to manufacturer.

Event Description

End user reports circumferential scattered red and raw skin under the mass but not under the moldable disc of the 1-piece moldable system.The end user reported that it was difficult to remove the part of the mass on the pouch that did not come in contact with the moldable disc" so she feels this is why her "skin is red and raw".Additionally,she said it seemed like it was pulling on her skin when she would remove it.The end user stated her skin has been red since having her stoma placed in (b)(6) of this year but the redness has worsened with this appliance.The end user did however mention that her pouch does completely fill with liquid stool at times during the night.

• Brand Name: ESTEEM® + MOLDABLE ONE-PIECE CLOSED POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; parque industrial itabo; s.a haina, san cristobal 3 ; DR 3
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5878508
• MDR Text Key: 52189492
• Report Number: 9618003-2016-00039
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 413510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: FLORINEF
• Patient Age: 37 YR
• Patient Weight: 64