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 that, the wafer was not cut enough.The product was not used.No photo is available at this time.

Manufacturer Narrative

Common device name: pouch, colostomy.Product code: ezq.Complainant state/province: kanagawa event country: japan.Pma /510(k) #: exempt.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.Manufacturing site: 1049092.

Manufacturer Narrative

E1: complainant state/province:(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.

Event Description

To date no additional patient or event details have been received.

Manufacturer Narrative

An investigation was completed for this complaint by the assigned manufacturing site investigation team.The complaint summary of this investigation required rework.A corrective actions/preventive actions (capa) was raised, and an updated/corrected investigation summary has been completed in accordance with assigned capa.A supplemental mdr is being submitted to document the completion of investigation rework and final investigation; the complaint record will proceed to closure.Lot 0000620231 was manufactured on 01/01/2022 and this was the only complaint found in database.Hence, no full cause investigation was carried out.This lot was not related to field safety notice (fsn) issued in 2019.No return samples were provided.No additional action is required, and this complaint 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.

Event Description

To date no additional patient or event details have been received.

• 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: 15951576
• MDR Text Key: 306068068
• Report Number: 1049092-2022-00420
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 422545
• Device Lot Number: 0000620231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2022
• 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