MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC 1PC-POUCH-ESTEEM+; POUCH, COLOSTOMY

Model Number 421819

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported the starter hole was off center in two wafers.No photo provided.

Event Description

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

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.Returned sample evaluation: there are no photographs associated with this case and no unused returned sample was received.Conclusion summary of the related event: based on the analysis performed, even though there was an increasing tendency of complaints related to ¿off center starter hole¿ during 2018 and beginning of 2019, the updated data shows a positive tendency after the corrections executed to the ats#1 and ats#2 machines.Current quality and manufacturing controls have demonstrated to be adequate and effective since no non-conformances have been generated during the production process associated to the same failure from january 2018 to september 30, 2020.Also, this failure mode will continue to be monitored by the leadership during the corrective actions/preventive actions (capa) review board (monthly) and management review (biannual) for track and trending.No additional action is considered necessary for this record.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.

• Brand Name: 1PC-POUCH-ESTEEM+
• 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: 8675443
• MDR Text Key: 147222986
• Report Number: 9618003-2019-04355
• Device Sequence Number: 1
• Product Code: EZQ
• 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,Distributor
• 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: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/24/2023
• Device Model Number: 421819
• Device Lot Number: 8K01411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1