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

Model Number 175783

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Fluid Discharge (2686)

Event Date 01/20/2015

Event Type  Injury  

Event Description

The end user reported that she developed a red weeping area under the adhesive barrier that extended downward to end of pouch.She was advised to see her physician, which she did and was prescribed nystatin.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Note: this issue occurred on (2) separate cases.A separate 3500a form has been completed for the other (1) case.

Manufacturer Narrative

Additional information received november 18, 2015.After detailed batch review of product associated with batch 4h02216, correction procedure documentation was found.Bulk pouches with streaks of incomplete adhesive a.K.A cold flow were identified.Cold flow looked like a dent or noticeably thinner area in molded adhesive.As part of the correction procedure a 100% inspection was conducted to remove all defective pouches from order in preparation for next production step.After rework all remaining product met specification.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation, is applicable to this complaint investigation.This previous investigation is open.Therefore, this complaint will remain open until completion of the previous investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No additional event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: ACTIVELIFE CONVEX ONE-PIECE PRE-CUT DRAINABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4584663
• MDR Text Key: 16180425
• Report Number: 1049092-2015-00142
• 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,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2019
• Device Model Number: 175783
• Device Lot Number: 4H02216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 03/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/11/2015; 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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
• Treatment: DULOXETINE; HYDROCODONE; CELECOXIB; LISINOPRIL; PRAMIPEXOLE; GABAPENTIN; BACLOFEN; FAMOTIDINE
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95