MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022759022759

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

Patient Problems Fungus (1872); Irritation (1941)

Event Date 07/31/2013

Event Type  Injury  

Event Description

End user stated she developed a fungal rash no her peristomal skin under the mas at the end of (b)(6) 2013.The end user stated the site was red and itchy.The end user also stated she was seen by her primary doctor who prescribed nystatin powder with little improvement.She was then seen by her dermatologist and reported her dermatologist stated it was fungal and prescribed triamcinolone cream 0.1 percent and the rash cleared up completely.The end user went onto state she has had no additional episodes since that time.

Manufacturer Narrative

Based on the available information this event is deemed a serious injury.The end user stated she uses (b)(6) soap, (b)(6) no sting protectant wipes and (b)(6) paste as a filler.The end user confirmed to lot number was available.No additional pt/event details have been provided to date.Should additional information become available a follow- up report will be submitted.A return sample for evaluation is not expected.

Manufacturer Narrative

A final quality evaluation was performed on (b)(6) 2014.Based on the evaluation of materials and processes, there is no change to the products that can indicate assignable situations that would account for the adverse events reported.The batch record review of affected lots was not conducted because there is no quality data record that can provide product usability testing.To the extent that the data can be evaluated without having any product samples returned for evaluation, a specific corrective action is not required.The risk review meeting, for this investigation and the evaluation of the calculated probabilities, was conducted.The conclusion derived at this meeting was that the trend was not significant and should be continued to be tracked and monitored against a threshold or baseline.Kin related field feedback and/or complaints info will continue to be tracked and evaluated according to convatec procedures.A lot number could not be obtained therefore a review of the batch record data could not be performed without a lot number.No additional patient/event details have ben provided to date.Should additional information become available an additional follow-up report will be submitted.

• Brand Name: ACTIVE LIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE
• 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: mary szaro, associate dir ; 200 headquarters park dr; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3675062
• MDR Text Key: 17611624
• Report Number: 9618003-2014-00021
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K833625
• 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,Followup
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022759022759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Weight: 73