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

Model Number 175763

Device Problem Difficult to Remove (1528)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Date 08/27/2016

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

End user reported that the mass disintegrates upon removal, it becomes balled up and it takes an hour to remove from her skin.As a result, she says her skin is red and irritated under the entire mass area.

Manufacturer Narrative

A query was run on against lot number 6c03836 for the reported malfunction and yielded only one (1) occurrence against the lot.As a result, a detailed investigation or batch review is not required at this time.If additional complaints occur with this batch and same malfunction, these subsequent complaints shall be assessed.This issue will be monitored through the post market product monitoring review process.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 ONE-PIECE PRE-CUT CLOSED-END POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5963001
• MDR Text Key: 55126116
• Report Number: 9618003-2016-00048
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/06/2021
• Device Model Number: 175763
• Device Lot Number: 6C03836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• 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: CEPHALEXIN; LEVOTHYROXINE
• Patient Age: 80 YR