MAUDE Adverse Event Report: CONVATEC INC. SUR-FIT NATURA 2 PC DRAINABLE INVISICLOSE; POUCH, COLOSTOMY, 78EZQ

Model Number 413335

Device Problem Leak/Splash (1354)

Patient Problem Fungus (1872)

Event Date 05/01/2014

Event Type  Injury  

Event Description

An end user stated due to the leakage of stool at the tail closure.The end user also stated he went to the dermatologist with a severe fungal infection in his crotch due to leakage without a protective diaper collecting it.

Manufacturer Narrative

Based on the available info, this event is deemed a serious injury.The end user stated "it got on my skin and it took a month to clear up." the end user also stated he went to the dermatologist and was prescribed an anti-fungal powder and aquaphor over the counter ointment.A lot number for the product was not available.No add'l pt/event details have been provided to date.Should add'l info become available, a f/u report will be submitted.A return sample for eval is not expected.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: SUR-FIT NATURA 2 PC DRAINABLE INVISICLOSE
• Type of Device: POUCH, COLOSTOMY, 78EZQ
• Manufacturer (Section D): CONVATEC INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, assoc. dir. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3848650
• MDR Text Key: 20654841
• Report Number: 9618003-2014-00048
• 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: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 413335
• Device Catalogue Number: 413335
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2014
• 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