MAUDE Adverse Event Report: CONVATEC, INC ACTIVELIFE CONVEX ONE PIECE PRE CUT DRAINABLE

Model Number 175779

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

The end user reported that she has had a rash under the tape collar "for months." she has been prescribed nystop powder and diflucan as well as a variety of other creams (names not provided).She also mentioned that she has tried applying different brands of bonding cement under her tape collar and stomahesive paste under her mass.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.Reported to fda on february 6 2015.

• Brand Name: ACTIVELIFE CONVEX ONE PIECE PRE CUT DRAINABLE
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4505980
• MDR Text Key: 21176228
• Report Number: 1049092-2015-00090
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/29/2015

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 Model Number: 175779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/09/2015
• 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 Age: 67 YR