MAUDE Adverse Event Report: CONVATEC , INC. ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE; POUCH, COLOSTOMY

Model Number 125333

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

Patient Problem Erythema (1840)

Event Date 08/30/2014

Event Type  Injury  

Event Description

The end-user reported circumferential redness under the white tape collar of the device.

Manufacturer Narrative

She stated it first started at the bottom and sides but is now under the tape at the top.The end-user has been using the product for eight years or more.She previously experienced itching in the area but that has passed.The end-user uses dial soap to cleanse her peristomal skin.The end-user saw her primary doctor who prescribed diflucan (fluconazole) and nystop (nystatin topical), which both required a prescription.She applies nystop followed by (b)(4) protective barrier wipes to the reddened area.The end-user was instructed to cut the white tape collar off of her pouch until she receives sample products.An esteem one-piece pouch without tape collar was recommended and samples were sent.She was instructed to call back if the area worsens or does not improve.Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC , INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR 3
• Manufacturer Contact: matthew walenciak,interim assoc d ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4227874
• MDR Text Key: 16302503
• Report Number: 9618003-2014-00091
• 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,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/13/2014

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: 125333
• Device Catalogue Number: 125333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 10/22/2014
• 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
• Patient Weight: 73