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

Model Number 416417

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

Patient Problems Skin Irritation (2076); Fungal Infection (2419)

Event Type  Injury  

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.Patient height: 61 inches.Reported to the fda on october 27, 2015.(b)(4).

Event Description

It was reported the end user developed irritated skin under the ostomy pouch near the tail closure.The end user advised she "has a lot of loose skin" in that region of her abdomen due to a recent 50-pound weight loss.After an examination, the end user's physician advised she had developed a "yeast-like" infection and the end user was issued a prescription for topical nystatin cream (to be applied two times/day for six weeks).No further patient complications were reported.

Manufacturer Narrative

The product associated with batch 5g03269 was made according to specification.After detailed batch review, a discrepancy was noted.Record review found deviation regarding air leak failure.Machine corrections were made and suspect product identified and discarded.No impact to this complaint.In addition, the quality system was queried for any non-conformances (nc) or deviations against the lots associated with final batch 5g03269.The results support that (nc) were raised against this issue.Product monitoring reviews will monitor for product trends if this issue were to reoccur.A previous (nc) is applicable to this complaint and has been closed.No further actions are required, and this complaint will be closed.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: NATURA® + DRAINABLE POUCH WITH INVISICLOSE®
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5179775
• MDR Text Key: 29294801
• Report Number: 1049092-2015-00619
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/04/2020
• Device Model Number: 416417
• Device Lot Number: 5G03269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VITAMIN B12
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 59