MAUDE Adverse Event Report: CONVATEC INC. ACTIVELIFE 1PC UROSTOMY POUCH W/ DURAHESIVE ; URINARY, ILEOSTOMY

Model Number 650831

Device Problems Occlusion Within Device (1423); No Flow (2991)

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

Event Date 04/21/2014

Event Type  malfunction  

Event Description

End user reports urine will not drop below anti reflux value in 10 pouches.It was reported that this issue occurred on (ten) separate cases.(report 3 of 10).

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.Additional patient/event information was requested on 05/13/2014.Please note: issue occurred on ten (10) separate cases.A separate 3500a form has been completed for the other (9) cases under patient identifier #(s) (b)(4).Manufacturer report#(s): 1049092-2014-00108, 1049092-2014-00109, 1049092-2014-00111, 1049092-2014-00112, 1049092-2014-00113, 1049092-2014-00114, 1049092-2014-00115, 1049092-2014-00116 and 1049092-2014-00117 respectively.( report 3 of 10).No additional patient/event details have been provided to date.Should additional information become available a follow- up report will be submitted.

Manufacturer Narrative

Additional information was received on september 08, 2015.No previous investigations are available.After a thorough batch review, no discrepancies (includes non-conformances/deviations) were found.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE 1PC UROSTOMY POUCH W/ DURAHESIVE
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3912918
• MDR Text Key: 4588120
• Report Number: 1049092-2014-00110
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2018
• Device Model Number: 650831
• Device Catalogue Number: 650831
• Device Lot Number: 3G016167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1