MAUDE Adverse Event Report: CONVATEC LIMITED SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 401502

Device Problems Misassembled (1398); Incomplete or Missing Packaging (2312); Packaging Problem (3007)

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

Event Date 09/01/2011

Event Type  malfunction  

Event Description

Details of complaint: "1 out of 10 pouches.Upon opening box noted one pouch small flange size.Expected 1, 3, 4 inch wafer.It was unable to determine exact size of small flange of pouch.".

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient being harmed as a result of this malfunction.No sample was available for evaluation.An evaluation was performed on (b)(4) 2011 based on the review of the batch records for lot 0m02378.Results showed no assignable root cause was identified and there were no discrepancies noted within the batch record related to this complaint issues.The retained product was evaluated and the evaluation results are as follows: the samples were visually inspected and all sample appeared to be in normal condition.Leak testing was performed and passes the established specification.A review of complaint trend for previous 12 months was performed and this is the only complaint of this type for this lot was received.There is no indication of complaint trend based on this review.No non-conformance reporting system for the previous 12 months of case creation.No product has been returned to convatec (b)(4).In conclusion based on the investigation conducted, this complaint is not confirmed.Note: this mdr is being reported as a result of a retrospective review of complaint records conducted by convatec for complaints received from (b)(4) 2011 - (b)(4) 2013.Note: the actual date of event is unknown, so the date used was the date convatec became aware.Convatec will continue to track and monitor such complaints according to convatec inc's complaint handling and capa procedures.

• Brand Name: SUR-FIT NATURA 2 PC - 2 PC DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, int, ass dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3908225
• MDR Text Key: 4583682
• Report Number: 1000317571-2014-00029
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/01/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/30/2015
• Device Model Number: 401502
• Device Catalogue Number: 401502
• Device Lot Number: 0M02378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2010
• 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