MAUDE Adverse Event Report: CONVATEC, INC. NATURA® STOMAHESIVE® FLEXIBLE 4" X 4" WAFER; PROTECTOR, OSTOMY

Model Number 125262

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

Patient Problems Itching Sensation (1943); Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Initial emdr is being re-submitted per request of fda on 30-apr-2021.Based on the available information, this event is deemed to be a serious injury.This complaint is not associated with a product malfunction.The complaint/incidence data-post market data analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints as a result of skin complications which are caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required, and this complaint will be closed.Product monitoring reviews will monitor for product trends if this issue were to reoccur.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 30-mar-2016.On 01-apr-2016, the following correction was identified: manufacture name, city and state updated.Manufacturer report (mfr) number was previously reported in error as 9618003-2016-00014 on the initial report, submitted to the fda on march 30, 2016.The new mfr# is 1049092-2016-00185.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on 26-apr-2016.(b)(4).

Event Description

The end user reported several month history of red bumpy rash under tape collar with intense itching.She stated that there was no weeping or drainage.She was seen by her gastrointestinal physician and then her surgeon who referred her to the ostomy clinic.The wound ostomy continence nurse recommended an over-the-counter anti-fungal powder, however the rash did not improve so she contacted her primary physician who prescribed nystatin.She had used the nystatin for several months now with some temporary improvement, however she reported the rash was worse now and the itching was driving her crazy.The rash was under 100 percent of the tape border and was a mirror image of the tape border.She reported that there had been no changes in medications, dosage or skin care routine.Patch testing was recommended on the opposite side of the abdomen to see if the same symptoms occurred in that location.No information had been received if patch testing was performed.The end user stated that she would see a dermatologist if there was no improvement.

• Brand Name: NATURA® STOMAHESIVE® FLEXIBLE 4" X 4" WAFER
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC, INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 5608015
• MDR Text Key: 263865291
• Report Number: 1049092-2016-00185
• Device Sequence Number: 1
• Product Code: EXH
• 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: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 125262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 60 KG