MAUDE Adverse Event Report: CONVATEC, INC. NATURA + DRAINABLE POUCH WITH INVISICLOSE; POUCH, COLOSTOMY

Catalog Number 416417

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

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed to be a reportable malfunction.No further information was available at the time of the report.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

End user reports that his stoma has prolapsed 6 to 8 weeks ago and a few weeks ago, he pinched the stoma when attaching the pouch to the wafer.According to the end user, the stoma had some initial bleeding but none since.He said that there is an irregularly shaped laceration measuring 1.25 cm and 4-5 mm in width with there is some yellow-gray tissue covering the wound.He is self treating with hollister wound cleanser and neosporin.End user states that the area is slowly but gradually improving.

• Brand Name: NATURA + DRAINABLE POUCH WITH INVISICLOSE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.5; parque industrial itabo, s.a.; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5980192
• MDR Text Key: 55723724
• Report Number: 9618003-2016-00050
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 416417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2016
• 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: PREDNISONE
• Patient Age: 63 YR