MAUDE Adverse Event Report: CONVATEC INC ESTEEM+; BAG, URINE COLLECTING, URETEROSTOMY

Model Number 422545

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported by the retailer that wafer had off centered started hole.The product was not used by patient.No photo is available at this time.

Manufacturer Narrative

E1: complainant state: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.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: BAG, URINE COLLECTING, URETEROSTOMY
• 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: 17196969
• MDR Text Key: 317809955
• Report Number: 1049092-2023-00165
• Device Sequence Number: 1
• Product Code: EXG
• UDI-Device Identifier: 00768455197859
• UDI-Public: 00768455197859
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 422545
• Device Lot Number: 0000737544
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2022
• 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