MAUDE Adverse Event Report: CONVATEC, INC. ACTIVELIFE - DRAINABLE POUCH W/DURAHESIVE; POUCH, COLOSTOMY

Model Number 175779

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

Patient Problem Tissue Damage (2104)

Event Date 09/29/2014

Event Type  Injury  

Event Description

It was reported by the end user a small round superficial wound at the nine o'clock position beside stoma and about a quarter inch in diameter.

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.End user states first noted wound in (b)(6) 2014.Has been seen at the wound ctr by a wound ostomy continence nurse (wocn).End user further reports she uses silver absorbent rope followed by duoderm to treat the wound.It was suggested using a flat 1-pc pouch.End user has f/u appointment at the wound clinic in the next few weeks.No pt/event details has been provided to date.Should add'l info become available, a f/u report will be submitted.Reported to the fda on (b)(4) 2014.Note: the actual date of event is unk, so the date used was the date convatec became aware.

• Brand Name: ACTIVELIFE - DRAINABLE POUCH W/DURAHESIVE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american ave.; greensboro NC 27409
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4193196
• MDR Text Key: 20772056
• Report Number: 1049092-2014-00536
• 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: 09/29/2014

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 Model Number: 175779
• Device Catalogue Number: 175779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2014
• Initial Date FDA Received: 10/21/2014
• 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