MAUDE Adverse Event Report: CONVATEC INC SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER W/ FLANGE W/ WHITE TAPE C; PROTECTOR OSTOMY

Model Number 404593

Device Problems Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 05/21/2013

Event Type  Injury  

Event Description

Patient reported leakage under the mass and developed a rash under mass that spread under the tape collar.Patient described the rash as scattered pimples.End-user admitted that wipes were used to clean the area, dried and applied powder and barrier wipes prior to the application of the wafer.The end user subsequent outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issues april 16, 2014.Device (s) listed in this report is (are) used for treatment, no diagnosis.Any additional info received regarding this event after filing this report shall be filed on a supplemental mdr.Analysis is taken from a trending report of evaluations or adverse events finalized may 2011.The data presented is from three different product applications.The report states that there are no significant trends.Brand name: sur-fit natura durahesive moldable convex skin barrier w/ flange w/ white tape collar and mold-to-fit opening (overall dimension 4.5" x 4.5").

• Brand Name: SUR-FIT NATURA DURAHESIVE MOLDABLE CONVEX SKIN BARRIER W/ FLANGE W/ WHITE TAPE C
• Type of Device: PROTECTOR OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4147513
• MDR Text Key: 4769992
• Report Number: 1049092-2014-11658
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830945
• 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: 05/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/28/2013
• 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
• Patient Weight: 61