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

Model Number 416740

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

Patient Problem Rash (2033)

Event Type  Injury  

Event Description

The end user reported she developed a red rash under the bottom tape collar of one-piece colostomy pouch.The end user contacted her physician regarding the rash and was prescribed nystop powder.The end user had not begun using the powder at the time of the report.According to the end user, the physician did not see the rash prior to issuing the prescription.No further info was reported.

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)(6).

• Brand Name: ESTEEM + CONVEX ONE-PIECE DRAINABLE PRE-CUT P
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4920952
• MDR Text Key: 6027217
• Report Number: 1049092-2015-00402
• 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: 07/08/2015

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: 416740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/15/2015
• 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: HYPERTENSION MEDICATIONS (NAMES UNK); THYROID; LIPITOR
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 66