MAUDE Adverse Event Report: CONVATEC INC NATURA STOMAHESIVE FLEXIBLE PRE-CUT 4" X 4"; POUCH, COLOSTOMY

Model Number 125280

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2014

Event Type  malfunction  

Event Description

It was reported by the end user prior to use that the device hole/landing zone was off center.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional pt/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

The product associated with this complaint investigation, was made according to specification.No previous investigations are available.After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: NATURA STOMAHESIVE FLEXIBLE PRE-CUT 4" X 4"
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 4317480
• MDR Text Key: 19719825
• Report Number: 9618003-2014-00100
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,consumer,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2019
• Device Model Number: 125280
• Device Lot Number: 4D02638
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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