MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Erythema (1840); Itching Sensation (1943); Fungal Infection (2419)

Event Type  Injury  

Manufacturer Narrative

Date of event (b)(6) 2015.Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.No sample was returned for analysis and no lot number was provided.An analysis of trends for complaints of this nature showed the no trends that would conclude the product did not meet specification, perform as intended and/or identify a root cause.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

End user reported that his skin is red, intact with itching under the tape collar of his device that has been present for the past two months.He saw his physician who diagnosed peristomal yeast and prescribed an unknown topical antifungal cream.The end user further reported that there was no improvement noted.He went on to report that he saw his wound continence nurse who recommended he trial a product without tape, but he declined and informed that he prefers to remain with his present appliance.

• Brand Name: ACTIVELIFE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5429128
• MDR Text Key: 193625275
• Report Number: 9618003-2016-00003
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 83
• Patient Sex: Male
• Patient Weight: 100 KG