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

Model Number 022765

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Mdr 9618003-2019-05646/initial 1 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 Description

Female end user reported that the starter hole was off centered and because of this the wear time was decreased.

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) ¿procedimiento de despeje de línea y chequeo de seguridad¿, 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, test methods (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 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: ACTIVELIFE
• 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: 9232729
• MDR Text Key: 163571025
• Report Number: 9618003-2019-05646
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455179190
• UDI-Public: 00768455179190
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/17/2023
• Device Model Number: 022765
• Device Lot Number: 8C03138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female