MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM + DRAINABLE POUCH EXTENDED WEAR; POUCH, COLOSTOMY

Model Number 416975

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Skin Discoloration (2074); Discharge (2225); Skin Inflammation (2443)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

The end user reported her peristomal skin is blistered with "areas of open, weepy and discolored skin the size of a volleyball." according to the end user, it was an issue with decreased wear time that resulted in the skin issue.She also stated that she ran out of her appliance and she then "placed nothing over her skin for 2 days and the liquid stool was pooling on her skin and caused the skin to worsen." she saw an emergency room physician who made an unknown diagnosis and prescribed an antibiotic (not otherwise specified).No lab testing was done.End user instructed in proper care of peristomal skin.

Manufacturer Narrative

The post market trend analysis, subject matter expert (sme) review, clinical review, and marketing review indicate that a perception in specific markets has caused a consistent rate of complaints by the end user because there is no wear time requirement for the ostomy skin barrier.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM + DRAINABLE POUCH EXTENDED WEAR
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5733178
• MDR Text Key: 47670850
• Report Number: 9618003-2016-00029
• 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,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2016
• 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 Age: 40 YR
• Patient Weight: 82