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

Model Number 022771

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

Patient Problems Rash (2033); Skin Discoloration (2074); Fluid Discharge (2686)

Event Date 09/03/2014

Event Type  Injury  

Event Description

The end-user reported she developed a rash on her abdomen beneath the tape collar from this product being placed on her while in the hospital.The area is red and weepy.

Manufacturer Narrative

She saw an ostomy nurse who recommended she see a physician.She saw her physician on (b)(6) 2014 and he prescribed fluconazole by mouth and recommended she apply stomahesive powder to the site and continue using wafers without the tape collar which is what she was currently applying.Based on the available info, this event is deemed to be a serious injury.No further info was available at the time of the report.A return sample for evaluation is not expected and the lot number was not provided.Should add'l info become available, a f/u report will be submitted.The actual date of event is unknown, so the date used was the date convatec became aware.(b)(4).

• 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.; san cristobal 3, haina ; DR
• Manufacturer Contact: matthew walenciak, int assoc dir ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4106053
• MDR Text Key: 4702641
• Report Number: 9618003-2014-00086
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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: 09/03/2014

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: Health Professional
• Device Model Number: 022771
• Device Catalogue Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/17/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 48