MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVELIFE; POUCH, COLOSTOMY

Model Number	022765
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Distress (2329)
Date of Event	04/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 9 of 10.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 or Problem Description
The end user stated that 10 pouches from 2 market units with the same lot number had off centered precut opening.Reportedly, 6 from one box and 4 from the other box were affected.The end user expressed frustration and did not use the products.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
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 standard operating procedure (sop) ¿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, process instruction (pi), ds, mt, tm and the results are satisfactory.Photograph, video and/or physical sample evaluation: no photographs associated with this case were received and no unused return sample was expected.Executive summary of the nc: based on the results of the preliminary investigation, the batch record reviews were performed, and no discrepancies were found.A revision of the improvements made to the process was performed, and actions have been implemented for this type of incidents.In addition, an upgrade of the guard robot arm, disc collar and pouch assembly process was performed.These improvements performed to the guard machine, contribute to the reduction of possible defects related to off center.The last batch received was manufactured prior to the implementation of these improvements.Furthermore, a complaints search conducted shows that no adverse trend was identified from january 2019 to august 2020 for this failure mode.This failure mode will keep monitoring for track and trending.For this reason, no additional investigation is needed.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.Reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: ACTIVELIFE
• Common Device Name: 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: 10019952
• Report Number: 9618003-2020-10742
• Device Sequence Number: 2813502
• Product Code: EZQ
• UDI-Device Identifier: 00768455179190
• UDI-Public: 00768455179190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 11/24/2024
• Device Model Number: 022765
• Device Lot Number: 9L01689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown