MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE ONE-PIECE DRAINABLE CUT-TOFIT POUCH

Model Number 022771

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Fungal Infection (2419)

Event Type  Injury  

Event Description

It was reported the end user developed an itchy, red rash under the mass and tape collar of the skin barrier.The rash extends beyond the skin barrier approx.25-50 millimeters.The end user's rash was examined by a physician on (b)(6) 2015 and was diagnosed as a yeast infection to the peristomal skin.The end user was issued a prescription for antifungal powder (nystop).The end user noted slight improvement to the area.Approx.Two weeks later, the end user developed a vaginal yeast infection and was treated with a prescription for diflucan.Two weeks later, the end user reportedly developed a urinary tract infection and was working with her urologist to determine the most appropriate course of treatment.No further information was reported.

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.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE CUT-TOFIT POUCH
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4948760
• MDR Text Key: 6640665
• Report Number: 9618003-2015-00040
• 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: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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?: No
• Date Manufacturer Received: 07/20/2015
• 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: Initial
• Patient Sequence Number: 1
• Treatment: ALLKARE ADHESIVE REMOVER; STOMAHESIVE PASTE; SINGULAR; DIFLUCAN; UNKNOWN ANTIBIOTIC; GABAPENTIN; ZYRTEC; ALLKARE PROTECTIVE BARRIER WIPES; ALOE VESTA CLEANSING FOAM
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 68