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

Model Number 411310

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

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Event Description

It was reported the end user developed a granuloma due to the filter on his pouch rubbing onto his stoma.End user was instructed to try a sample of the plus pouch since the filter on this pouch will not come in contact with his stoma.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Additional information received november 19, 2015.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.(b)(4).No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: SUR-FIT NATURA INVISICLOSE DRAINABLE POUCH
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 4807979
• MDR Text Key: 5892685
• Report Number: 9618003-2015-00026
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 411310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2015
• 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
• Treatment: VITAMIN D; VITAMIN B12; TESTOSTERONE
• Patient Outcome(s): Other
• Patient Age: 45 YR