MAUDE Adverse Event Report: CONVATEC LTD ESTEEM+ FLEX CONVEX; I

Model Number 421626

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

Patient Problems Bacterial Infection (1735); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Pouch, colostomy.Based on the available information, this event is deemed to be a serious injury.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that approximately three weeks ago the end user developed an open pressure injury due to her hernia and use of the convex flex pouching system.The wound was to the peristomal skin near the stoma at the twelve o'clock position.End user was seen in outpatient clinic for the open wound and fitting of ostomy.End user was provided a collagen type dressing to place over the wound as well as a new pouching system, brand unknown.Follow up information indicated the end user was treated with silver hydrofiber and hydrocolloid along with an oral antibiotic (brands and name is unknown).It was further reported that the end user was evaluated by a dermatologist and a swab culture of the open wound tested positive for klebsiella pneumonia.The end user was prescribed amoxicillin-clavulanate and cefpodoxime.It was noted that the end user is using an alternate product and it is unknown if it is a convatec product.No further information has been provided.

• Brand Name: ESTEEM+ FLEX CONVEX
• Type of Device: I
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409
• MDR Report Key: 8128722
• MDR Text Key: 129180322
• Report Number: 1049092-2018-00599
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 421626
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78