MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ESTEEM+ CMT; POUCH, COLOSTOMY

Model Number 413522

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 10.(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.(b)(4).

Event Description

The end user reported that the wafer had an off-centered starter hole, which led to difficulty for the end user to use ease stripes as extra bandaging at the edges.The product was used by the end user.Picture of the alleged malfunction was provided by the complainant.

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: d4: unique identifier (udi) h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary batch record review: the batch record review supports that there were no discrepancies related to the issue reported.This batch was manufactured following the applicable procedures, all machine and testing parameters were in accordance with the applicable procedures and specifications, the testing results were found satisfactory and no nonconformance related to the malfunction code in analysis was noted.The line clearance was executed per dr (b)(4) ¿line clearance procedure and security check¿ the results were documented, and no issues were identified during the manufacturing process.The materials comply with the correct parameters, procedure instruction (pi), ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect could not be seen.No unused return sample was expected.Executive summary of the nonconformance (nc): during the event summary and impact evaluation of this nonconformance report (ncr), with the support of the triage team expertise and the analysis of the applicable pfmeas, the most probable causes of the problem were identified.In addition, quality tests are performed in the line, in order to identify this failure mode in our manufacturing process.Also, photos were received for one complainant and the issue could not be confirmed.Complaints search conducted shows that no adverse trend was identified from january 2019 to february 2021 for this failure mode.This failure mode will keep monitoring for track and trending.The investigation associated with related event has been approved and is 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 manufacturing site: 9618003.

Event Description

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

• Brand Name: ESTEEM+ CMT
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 9394253
• MDR Text Key: 176668285
• Report Number: 9618003-2019-14947
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455187829
• UDI-Public: 00768455187829
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/07/2022
• Device Model Number: 413522
• Device Lot Number: 7K06211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1