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

Model Number 413156

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2012

Event Type  malfunction  

Event Description

Report received indicated the pt's usual wear time is 5-7 days but 5 wafers were used and each only lasted for 1-2 days because the flange ring lifted from the mass.No further info was provided and the pt outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued 04/16/2014.Device(s) listed in this report is (are) used for treatment, not diagnosis.Any add'l info received regarding this event after filing this report shall be filed on a supplemental mdr.The review found that in process sampling and testing of intermediate sub-assemblies and the finished product was performed and documented throughout the order as per process requirements.The components used were approved for use as per quality system requirements.The product was made according to spec using validated processes.The product was evaluated and released by quality assurance according to quality system requirements.

• Brand Name: S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew walenciak, dir., post mar ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4068118
• MDR Text Key: 18923986
• Report Number: 1049092-2014-10891
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K855018
• 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: 08/16/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2016
• Device Model Number: 413156
• Device Lot Number: 1H00126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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