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

Model Number 411804

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091)

Event Date 09/07/2011

Event Type  Injury  

Event Description

End user reported he began itching around the hydrocolloid collar of the wafer and noted only a slight redness to the 4 to 6 o'clock area under hydrocolloid collar with a few bumps.Report also indicated itching beyond the wafer and left quadrant of abdomen and chest.Pt outcome was not reported.

Manufacturer Narrative

Convatec is submitting this report as a result of remediation activities related to the fda 483 issued april 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.Analysis is taken from a trending report of evaluations or adverse events finalized (b)(4) 2011.The data present is from (b)(4) different product applications.The report states that there are no significant trends.

• Brand Name: S4S/SUR-FIT NATURA 2 PC - 2 PC DURAHESIVE (DH)
• Type of Device: COLLECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC
• Manufacturer Contact: matthew walenciak, director ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4059002
• MDR Text Key: 14874994
• Report Number: 1049092-2014-10217
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 09/14/2011

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: 06/29/2016
• Device Model Number: 411804
• Device Lot Number: 1F02677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2011
• Initial Date FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 95