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

Model Number	422546
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions h11: investigation summary root cause analysis: in the case of the convex base plate, the starting hole can deviate from the center by -+ 2 mm when the cutting guide, starting hole, etc.Are glued.On the other hand, the convex/cutting process (kka3) also has a tolerance of +-2 mm (if the results of the two processes are off-center in one direction, the total is +-4 mm).Any baseplate where deviation affect the maximum cut area of the baseplate by overlapping the maximum cut area with the convex plastic ring under must be rejected.This means that the final product is out of tolerance.As the identification is performed by humans, retraining is carried out to keep the operator's awareness active to minimize the likelihood of an error.Immediate & preventive action(s) -immediate actions: traceability checked during production 20,017 pieces of production 37 pieces were rejected due to a starter hole out of tolerance.Preventive action: as we have no evidence and no details of the complaints are known, we can only assume that the reason for the complaints could be the same as the reason for the rejection during production.As we have no additional information on the reported complaint, we will train and sensitize employees on our specifications to minimize the likelihood of an off-center starter hole being overlocked.Staff awareness training will be carried out in several phases up to and including 21 february 2025 please send us photos/ and /or detailed information regarding the error for more effectiveness our actions.Supplier investigation report attached to child investigation record.Investigation report was completed by supplier for life and the documents for approval of the inspection report was checked and no discrepancies found.Also, without photo evidence or sample been returned it cannot be determined if the tolerances were exceeded.The investigation associated with related event record has been approved and was complete.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 or Problem Description
To date no additional patient or event details have been received.
Event or Problem Description
It was reported by the distributor that the wafer had off center starter hole.The product was not used by patient.A photograph depicting the issue was received from the complainant.
Additional Manufacturer Narrative
E1: complainant state: (b)(6).Complainant country: japan.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+
• Common Device Name: BAG, URINE COLLECTING, URETEROSTOMY
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 20661417
• Report Number: 1049092-2024-00127
• Device Sequence Number: 8502925
• Product Code: EXG
• UDI-Device Identifier: 00768455197866
• UDI-Public: 00768455197866
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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: Other
• Device Model Number: 422546
• Device Lot Number: 0001136652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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: Unknown