MAUDE Adverse Event Report: CONVATEC, INC. COMBIHESIVE NATURA STOMAHESIVE FLEXIBLE WAFER; POUCH, COLOSTOMY

Model Number 402220

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the product was dirty.One photograph was provided which appears to show black specks in the product.No patient harm reported.

Manufacturer Narrative

A batch record review for lot # 6e02814 was performed and indicates no discrepancies, deviations or non-conformances.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according to the process instructions.The process requirements results were documented in the product batch records and the product was packaged and labeled under the packaging and labeling specification.No physical sample or photographs are expected.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 11, 2016.

• Brand Name: COMBIHESIVE NATURA STOMAHESIVE FLEXIBLE WAFER
• 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: 5826850
• MDR Text Key: 50580087
• Report Number: 9618003-2016-00036
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2021
• Device Model Number: 402220
• Device Lot Number: 6E02814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2016
• 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