MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA® DRAINABLE POUCH, 12"; POUCH, COLOSTOMY

Model Number 401514

Device Problems Material Too Rigid or Stiff (1544); Scratched Material (3020)

Patient Problems Skin Irritation (2076); Tissue Damage (2104)

Event Type  malfunction  

Manufacturer Narrative

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 november 15, 2016.(b)(4).

Event Description

End user reported that due to an irregularity in the pouch film the stoma developed 2 to 3 reddened blood dots on the stoma in the position where the pouch film touched the stoma.According to the end user, there was no pain or medical intervention.She was advised to stop using the product in question.

• Brand Name: SUR-FIT NATURA® DRAINABLE POUCH, 12"
• 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: 6104379
• MDR Text Key: 59978122
• Report Number: 9618003-2016-00057
• 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

• Date FDA Received: 11/15/2016
• 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
• Date Manufacturer Received: 10/25/2016
• 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