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

Model Number 421628

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Type  Injury  

Event Description

The end user has been using other company¿s product since his urostomy surgery two years ago.He developed a severe reaction and was put on antibiotics, prednisone and a cream.They believed he had a reaction to the other company¿s product adhesive.He started wearing company¿s pouch on (b)(6) 2024.His all the medications had been finished, and he started with the same reaction.It is an all-body rash not specific to under the appliance alone.It was worse on the edge of the appliance and on his chest.It was stated at time of reporting this event that he would be going to see an allergist soon on monday (b)(6) 2024 and a nswoc (nurse specialized in wound, ostomy and continence) on wednesday.Further, it was stated that nothing was prescribed at this time.No photo is available at this time.

Manufacturer Narrative

E1: complainant street address: (b)(6).(b)(6).Other company's name: (b)(4).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.Fda registration number.Reporting site: 1049092.Third party manufacturing site (for life): 3003759552.

• Brand Name: ESTEEM+
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18976567
• MDR Text Key: 338549516
• Report Number: 1049092-2024-00028
• 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: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 421628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male