MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM + ONE-PIECE PRE-CUT CLOSED-END POUCH; POUCH, COLOSTOMY

Model Number 416707

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

Patient Problems Abrasion (1689); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994)

Event Date 10/01/2014

Event Type  Injury  

Event Description

The end user reported that two months ago he experienced an allergic reaction under his tape collar.He stated that his skin became red, raw, and broken and presently it is sore and itchy.He seen his general physician and was diagnosed with adhesive allergic reaction and prescribed hydrocortisone cream and two others creams (names not provided).The end user stated the creams worked for a period of time but the symptoms return once the creams are stopped.The end user also mentioned that he has used this product for years and never had an issues.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: ESTEEM + ONE-PIECE PRE-CUT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4473400
• MDR Text Key: 5496031
• Report Number: 9618003-2015-00004
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2014
• 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