MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ACTIVELIFE 1PC DRAINABLE POUCH W/ STOMAHESIVE; POUCH, COLOSTOMY

Model Number 022771

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 12/05/2013

Event Type  Injury  

Event Description

End user reported several week histories of burning and pian under mass on second day of wearing.End user stated there are no discoloration or any open areas.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.End user reported she uses (b)(4) soap to clean then adds (b)(4) layer on skin and (b)(4) powder over that along with smith and nephew skin-prep over the top.She reported that she changes pouches every seven days.Skincare was reviewed with the end user and she was advised to switch to no sting wipe.She was advised to stop (b)(4) and to only use powder if itching or when she has open areas.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow-up report will be submitted.Note: the actual date of event is unknown, so the date used was the date convatec became aware.

• Brand Name: ACTIVELIFE 1PC DRAINABLE POUCH W/ STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: mary szaro, director ; 200 headquarters park dr.; skillman, NJ 08558 ; 9089042450
• MDR Report Key: 3571150
• MDR Text Key: 19974681
• Report Number: 9618003-2014-00002
• Device Sequence Number: 1
• Product Code: EXB
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022771
• Device Catalogue Number: 022771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2013
• 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 Weight: 67