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

Model Number 022771

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/06/2013

Event Type  Injury  

Event Description

End-user reported intermittent bleeding from stoma for five (5) months due to the hole for opening size is too small.It is reported that there is a small amount of bleeding; however, the quantity is unk.It is also reported that the product has been in use for two (2) years.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.It is reported that end-user required chemical cauterization with silver nitrate prescribed by dr (b)(6); surgeon at (b)(6) 2013.It is reported that this treatment has resolved the bleeding.Lastly, end-user was instructed to resize barrier and has requested samples.Samples were sent to end-user.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.

• Brand Name: ACTIVELIFE 1 PC DRAINABLE POUCH W/STOMAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC 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: 3571155
• MDR Text Key: 20329572
• Report Number: 9618003-2014-00004
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/06/2013

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: 12/06/2013
• 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 Outcome(s): Required Intervention
• Patient Weight: 93