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

Model Number 413180

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Discoloration (2074)

Event Type  Injury  

Event Description

Report received indicated the pt experienced an intermittent red and itching rash under the mass and adhesive border.The pt experienced the condition during an unk period prior to complaint receipt.Pt uses eakin seal with the device.Pt was treated with nystatin.Pt outcome was not noted.

Manufacturer Narrative

(b)(4).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.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH) CONVEX WAFER
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir, post mark ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3987332
• MDR Text Key: 4755507
• Report Number: 1049092-2014-10041
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K855018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2016
• Device Model Number: 413180
• Device Lot Number: 1C01526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2014
• Initial Date FDA Received: 07/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 76