MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA® INVISICLOSE® DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 411362

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

Patient Problems Abrasion (1689); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on july 21, 2016.(b)(4).

Event Description

The end user reported the filter on the pouch scraped her stoma causing slight bleeding.According to the end user, the pouch is transparent and she noted small amount of blood over the stoma.She removed the pouch and washed the area, noting a small quarter inch abrasion on the stoma.There was no more bleeding.

• Brand Name: SUR-FIT NATURA® INVISICLOSE® DRAINABLE 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 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5814167
• MDR Text Key: 50190085
• Report Number: 9618003-2016-00033
• 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: Patient
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2020
• Device Model Number: 411362
• Device Lot Number: 5F03358
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2015
• 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 Age: 65 YR
• Patient Weight: 61