MAUDE Adverse Event Report: CONVATEC INC ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE DH

Model Number 175779

Device Problem Human-Device Interface Problem (2949)

Patient Problem Itching Sensation (1943)

Event Type  Injury  

Event Description

Report received indicated that patient experienced itching under the tape collar on the right side of abdomen, and has worsened over time.Report also noted that patient experienced the condition during a period of one to two days prior to complaint receipt.Skin appears splotchy and red in varying locations.The patient cleanses with an unk brand of soap and water then rinses and applies the barrier.The wear time is seven days and patient wears the appliance in the shower.Skin care was reviewed with the end user.Patient outcome was not noted.

Manufacturer Narrative

Convatec is submitting the report as a result of remediation activities related to the fda (b)(4) 2014.Devices listed in this report are used for treatment, not 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 in (b)(4) 2011.The data presented is from three different product applications.The report states that there are no significant trends.

• Brand Name: ACTIVELIFE 1PC-1PC DRAINABLE POUCH W/ DURAHESIVE DH
• Manufacturer (Section D): CONVATEC INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4053496
• MDR Text Key: 4807684
• Report Number: 1049092-2014-11125
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• 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: 11/30/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/25/2017
• Device Model Number: 175779
• Device Lot Number: 2F02329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 57