MAUDE Adverse Event Report: CONVATEC INC S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) FLEXIBLE WAFER; PROTECTOR, OSTOMY

Model Number 413161

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Report provided by the (b)(6) call center states that the end user has experienced leakage with 6 out of 10 wafers within the same box and the lot number.The pts subsequent outcome was not noted.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued (b)(4) 2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.The batch record review was performed.In process sampling and testing of intermediate sub-assemblies and the finished product was performed and documented.Components were approved for use.There was no objective evidence that the product did not meet specifications based on the review of the batch record and data review.

• Brand Name: S4S/SUR-FIT NATURA 2PC-2PC DURAHESIVE (DH) FLEXIBLE WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4099151
• MDR Text Key: 20018349
• Report Number: 1049092-2014-11386
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• PMA/PMN Number: K830945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2017
• Device Model Number: 413161
• Device Lot Number: 2H00671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1