MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE ONE-PIECE DRAINABLE POUCH; POUCH, COLOSTOMY

Model Number 400598

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

The end user reported that the pouches side seams were jagged and rough.

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No additional patient'/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Note: issue occurred on 4 separate cases.A separate 3500a form has been completed for the other 3 cases.

Manufacturer Narrative

Additional information was received on (b)(6) 2015.No previous investigations are available.After review of the returned product and a thorough batch review, no discrepancies were discovered.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.

• Brand Name: ACTIVELIFE ONE-PIECE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC. ; carretera sanchez, km. 18.2; parque industrial itabo; s.a. haina, san cristobal 3 ; DR
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4745069
• MDR Text Key: 5709364
• Report Number: 9618003-2015-00017
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2019
• Device Model Number: 400598
• Device Lot Number: 4G00258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2015
• Date Manufacturer Received: 10/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 56 YR