MAUDE Adverse Event Report: CONVATEC, INC. SUR-FIT PLUS CONVATEC MOULDABLE TECHNOLOGY W; POUCH, COLOSTOMY

Model Number 411821

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

Patient Problem Skin Irritation (2076)

Event Date 04/07/2015

Event Type  Injury  

Event Description

It was reported the end user developed an allergic reaction (symptoms unspecified) around the stoma, under the device and, in the same location of an ongoing herpes zoster infection.Initially, the patient was advised by a nurse to treat the affected area with a protective powder (stomahesive) but no improvement was noted.The patient presented to his physician and was reportedly informed the allergic reaction occurred as a result of the infected skin.The patient was issued an unknown prescription ointment to treat the herpes zoster infection.Since using the ointment, the patient has noted improvement to the skin impacted by the allergic reaction.No further information was provided.

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: SUR-FIT PLUS CONVATEC MOULDABLE TECHNOLOGY W
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4790422
• MDR Text Key: 5854000
• Report Number: 9618003-2015-00025
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 411821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR