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

Model Number 401557

Device Problem Component Missing (2306)

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

Event Date 07/09/2014

Event Type  malfunction  

Event Description

An end user reported that two devices out of the sample pack were missing the anti-reflux valve.

Manufacturer Narrative

Based on the available information this event is deemed a reportable malfunction.It was stated the end user threw away the sample package and cannot provide the lot number.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: SUR-FIT NATURA 2PC DRAINABLE POUCH HIGH OUTPUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3979524
• MDR Text Key: 4635213
• Report Number: 9618003-2014-00068
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 401557
• Device Catalogue Number: 401557
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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