MAUDE Adverse Event Report: CONVATEC INC ESTEEM SYNERGY; PROTECTOR, OSTOMY

Model Number 411658

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Malposition of Device (2616)

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

Event Type  malfunction  

Manufacturer Narrative

Mdr 1049092-2022-00523 / device 5 of 10.The product is beyond its expiration date 10th february 2021.Expiry date is not on all ostomy products, therefore end user will not be aware of using expired product.(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: (b)(4).

Event Description

It was reported that the starter hole of the wafers was not centered.The product was used and caused leakage.The photographs depicting the issue were received from complainant.

• Brand Name: ESTEEM SYNERGY
• Type of Device: PROTECTOR, OSTOMY
• 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: 15985910
• MDR Text Key: 308137613
• Report Number: 1049092-2022-00523
• Device Sequence Number: 1
• Product Code: EXE
• UDI-Device Identifier: 10768455117342
• UDI-Public: 00768455186983
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2021
• Device Model Number: 411658
• Device Lot Number: 6A02638
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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: Female