MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1 PC - DRAINABLE POUCH W/DURAHESIVE; POUCH, COLOSTOMY 78 EZQ

Model Number 175780

Device Problem Increased Sensitivity (2535)

Patient Problem Rash (2033)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It is reported that end-user developed a rash to the skin located under wafer and/or tape collar (exact location unknown).It is further reported that end-user saw doctor last week who ordered treatment of the rash with prescribed oral antibiotics.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.Report states that the device was in use for one (1) or two (2) days before issue occurred, and alternate product sample has been sent to end-user.No additional patient/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.Convatec will continue to track and monitor such complaints according to convatec inc's.Complaint handling and capa procedures.

• Brand Name: ACTIVELIFE 1 PC - DRAINABLE POUCH W/DURAHESIVE
• Type of Device: POUCH, COLOSTOMY 78 EZQ
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3904192
• MDR Text Key: 4428221
• Report Number: 1049092-2014-00247
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 175780
• Device Catalogue Number: 175780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• 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