MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE® ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 022771

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

Patient Problems Cellulitis (1768); Pressure Sores (2326); Fungal Infection (2419)

Event Date 09/26/2015

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 16, 2015.(b)(4).

Event Description

A pharmacy technician reported "end user has peristomal skin issues which has been ongoing for several weeks.It was further reported that the end user saw an emergency department physician for the peristomal skin issue who diagnosed the end user with cellulitis with ulcers and infection including yeast.The physician prescribed a compound topical cream of triamcinolone; bactroban; nystatin and maalox for the affected area.Also, oral diflucan and clindamycin were also prescribed.The physician also requested that the patient be hospitalized for the ulcers but the end user declined.The physician also recommended that the end user use a non-adhesive appliance or one with a gentle adhesive was.".

• Brand Name: ACTIVELIFE® ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5,; arque industrial itabo; s.a. haina, san cristobal 3 33102 ; DR 33102
• Manufacturer (Section G): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5155576
• MDR Text Key: 28445418
• Report Number: 9618003-2015-00058
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• 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: 73 YR