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

Model Number 022767

Device Problem Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 that the precut starter holes in the mass were cut off center.No harm was reported and no photo was provided.

Manufacturer Narrative

Batch record review: lot 8d00477 was manufactured on 04/17/2018 in the guard line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 02/08/2019 to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom (bill of materials), ds10-034 (system 5 drainable ostomy pouch with stomahesive skin barrier), process instructions (pouch disc collar assembly system 5 b (guard machine), and all the tooling information documented was also correct, under international commodity code (icc) code 22767 system application product (sap) material identification (id) 1003062 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.Photo/sample analysis: no photos/samples were received related to the reported problem.Investigation conclusion: based on the investigation findings through revision of the batch records documentation, process observation, personnel interviewed, methodology implemented and defects simulation, the root cause could not be identified.Nevertheless, there is one (1) condition that could be considered, based on objective evidence, as a contributor factor for this event: there is not control in place for centering pins in the guard line.No issues related to machine, material, method, measurement or environment were identified during the manufacturing process evaluation, therefore no further actions are required related to these factors.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: 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: 8065321
• MDR Text Key: 126969446
• Report Number: 9618003-2018-03337
• Device Sequence Number: 1
• Product Code: EZQ
• UDI-Device Identifier: 00768455179213
• UDI-Public: 00768455179213
• 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: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/16/2023
• Device Model Number: 022767
• Device Lot Number: 8D00477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/20/2023
• 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
• Patient Sex: Female