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

Model Number	411658
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Mdr 1049092-2022-00527 / device 9 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.Complainant street address: (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).

• Brand Name: ESTEEM SYNERGY
• Common Device Name: 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: 15985946
• Report Number: 1049092-2022-00527
• Device Sequence Number: 5636442
• Product Code: EXE
• UDI-Device Identifier: 10768455117342
• UDI-Public: 00768455186983
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female