MAUDE Adverse Event Report: CONVATEC INC SUR-FIT NATURA STOMAHESIVE SKIN BARRIER W/ FLANGE W/O TAPE COLLAR AND W/ CUT-TO; PROTECTOR OSTOMY

Model Number 401576

Device Problem Human-Device Interface Problem (2949)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 06/19/2013

Event Type  Injury  

Event Description

Patient finance reported that a red rash area was noted when appliance was removed at 6 o' clock position around the stoma.Patient cleansed area with soap and water and pat dry area.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 (b)(4) 2011.The data presented is from (b)(4) different product applications.The report states that there are no significant trends.Brand name: sur-fit natura stomahesive skin barrier w/ flange w/o tape collar and w/ cut-to-fit opening (overall dimension 4" x 4").

• Brand Name: SUR-FIT NATURA STOMAHESIVE SKIN BARRIER W/ FLANGE W/O TAPE COLLAR AND W/ CUT-TO
• 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: 4147526
• MDR Text Key: 4789128
• Report Number: 1049092-2014-11761
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800750
• 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: 06/19/2013

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: 401576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2013
• 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 Outcome(s): Required Intervention
• Patient Weight: 30