MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM +; POUCH, COLOSTOMY

Model Number 416724

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994); Tissue Damage (2104); Reaction (2414)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.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

The end user reported that three weeks ago, the skin underneath her entire appliance was red and painful.The redness progressed to cover her entire torso, which progressed to her scalp and later progressed to her legs.She then developed what she described as oozing sores on her entire body.Thereafter, she was treated by her dermatologist with oral antibiotics (cephalexin).She was also given an antibiotic cream to treat the sores on her legs.The end user had completed the course of antibiotics a few days ago.Reportedly, her skin condition had improved.She was using stoma powder as needed to the peristomal skin and cleaned her skin with water when she changed her appliance.The end user did not continue to use the product and changed to a different brand of appliance.However, she now felt that the red skin condition was returning with the new product, and she noted new sores on her legs.No photo is available at this time.

• Brand Name: ESTEEM +
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 10647649
• MDR Text Key: 210359042
• Report Number: 9618003-2020-14572
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416724
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 66