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

Model Number 401514

Device Problem Scratched Material (3020)

Patient Problem Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.Additional information has been requested but none was available at the time of the report.Should additional information become available, a follow-up report will be submitted.

Event Description

Complaint reported by end user that due to an irregularity in the pouch film, her stoma developed 2 to 3 reddened blood dots in the position where the pouch film touches the stoma.The defect on the pouch film was noted as a marking or niche in the pouch film located on the inside of the pouch.According to the end user, there was no pain or medical intervention.She stated that the defects were noted prior to use on all pouches, however, she choose to use them anyway.The end user was advised to stop using the product.No further details have been provided.

• Brand Name: SUR-FIT NATURA® DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, 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: 6100354
• MDR Text Key: 59883424
• Report Number: 9618003-2016-00056
• 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: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2020
• Device Model Number: 401514
• Device Lot Number: 5B02883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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
• Treatment: VALIUM
• Patient Weight: 71