MAUDE Adverse Event Report: CONVATEC, INC ESTEEM AND CONVEX ONE-PIECE DRAINABLE PRE-CUT; POUCH, COLOSTOMY

Model Number 416738

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

Patient Problems Pain (1994); Skin Erosion (2075)

Event Date 01/01/2014

Event Type  Injury  

Event Description

End user reports approximately five weeks ago she noted an open area located at the right upper quadrant at the 1-5 o'clock position of her peristomal skin under the mass that measures 55x23mm and is painful.She saw an ostomy nurse who recommended a non-adhesive sys, by applying duoderm extra thin to the back of the barrier to create a non-adhesive sys; to be utilized along with a competitors product.She stated she had seen a dermatologist, who prescribed protopic ointment.She further stated that a biopsy was done to the open area to determine if the open area might be related ot her med condition pyoderma gangrenosum and a gastroenterologist performed a colonoscopy to rule out a flare up of her crohn's disease.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.(b)(4).

• Brand Name: ESTEEM AND CONVEX ONE-PIECE DRAINABLE PRE-CUT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4381435
• MDR Text Key: 19613661
• Report Number: 1049092-2014-00666
• 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: 12/01/2014

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: 416738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 12/31/2014
• 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
• Treatment: ENALAPRIL; CARVEDILOL; HOLLISTER 2-PIECE SYS; HYDROCHOLOROTHIAZIDE; PREVACID; SIMVASTATIN
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 73