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

Model Number	421631
Medical Device Problem Codes	Complete Blockage (1094); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 2 of 15.Common device name - pouch, colostomy.End user: (b)(6).Phone #: (b)(6).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: reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
This emdr is being submitted for fifteen appliances from two market units with same company's known lot.The end user reported to retailer who, afterwards, reported to company that after application of cut-to-fit water, brown material around the stoma seemed to melt and wafer opening gradually closed over his stoma.He stated that he cut the opening of the wafer to one-inch and on the second day after application the one-inch hole of wafer around the stoma had decreased in size to one and half inch and it almost covered his stoma.The end user, on further requesting an additional information, reported that the stoma size was twenty-five mm or one inch.He reported that when he removed the wafer on the fourth day, the wafer closed over his flush stoma and due to that the output was obstructed.There was no medical intervention or treatment was needed.No photo is available at this time.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary no sample, video or photo was received for evaluation; for that reason, the malfunction reported by the customer could not be confirmed.Lot 2e02776 was manufactured on 24 may 2022 in the 23a manufacturing line, with a total of (b)(4) market units (mkus).On (b)(6) 2023, compliance engineer performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom), under system application product (sap) material 1715117 and manufacturing order (b)(4).The testing results were found satisfactory.Therefore, no discrepancy related to this issue were found within the documentation.In addition, bulk lots 2c05169 & 2d04027 sap material 1716226, manufactured in 2b line were reviewed and no issues found.On (b)(4) 2023, a complaint search for lot 2e02776 and malfunction code - skin barrier migrates and obstructs stoma, was carried out and as a result, no additional complaints were found; therefore, no potential trend was observed and this case was considered an isolated incident.As per complaint manufacturing investigation procedure work instruction (wi), it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed and no potential trend was identified (therefore, considered an isolated incident).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 manufacturing site: 9618003.

• Brand Name: ESTEEM
• Common Device Name: BAG, URINE COLLECTING, URETEROSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 16213086
• Report Number: 9618003-2023-00130
• Device Sequence Number: 4340930
• Product Code: EXG
• UDI-Device Identifier: 00768455189885
• UDI-Public: 00768455189885
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 05/23/2024
• Device Model Number: 421631
• Device Lot Number: 2E02776
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2022
• 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: Male