MAUDE Adverse Event Report: ACTIVELIFE; BAG, URINARY, ILEOSTOMY

Model Number 125365

Device Problems Material Separation (1562); Delamination (2904)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

End user reported that she has ¿ongoing issues of leakage resulting from separation of the plastic pouch film from the mass.¿.

Event Description

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

Manufacturer Narrative

No samples or photos were received for analysis and investigation; for that reason, the malfunction reported by the customer could not be confirmed.In addition, a complaint search for lot 7b06106 and malfunction code for, inner film layer exposed (i.E moldable skin barrier layers separate or delaminate from inner film layer) was carried out and as a result, no additional complaint was found; therefore, no trend is observed.As per complaint manufacturing investigation procedure work instructions (wi), it is not required to open a nonconformance report (ncr) for this type of complaints which were not confirmed.Lot 7b06106 was manufactured on 16 march 2017, econo i line, with a total of (b)(4) units.Complaint investigator performed a batch record review on 28 september 2020, description active life pch uro cvx 25mm (1x10pk) us to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct.System application product (sap) material 1172464 and manufacturing order (b)(4).The batch record review supports that there were no discrepancies related to the issue reported.No additional action is required, and this complaint will be closed.This issue will be monitored through the post market product monitoring review process.No additional event detail information has been provided to date.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

• Brand Name: ACTIVELIFE
• Type of Device: BAG, URINARY, ILEOSTOMY
• MDR Report Key: 7306456
• MDR Text Key: 101602872
• Report Number: 9618003-2018-00024
• Device Sequence Number: 1
• Product Code: EXH
• 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
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/26/2022
• Device Model Number: 125365
• Device Lot Number: 7B06106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR