MAUDE Adverse Event Report: NATURA; PROTECTOR, OSTOMY

Model Number 404594

Device Problem Leak/Splash (1354)

Patient Problems Abscess (1690); Unspecified Infection (1930); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.A previous investigation is applicable to this complaint.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No further actions are required.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.Additional patient/details have been requested but no further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

The end user reported that he had ulcers that appeared under the flange part of the wafer off and on, and that the last ulcer abscessed and had to be packed with dressings to heal.He stated that the abscessed ulcer was approximately 1/2-inch deep.The end user stated there was an infection diagnosis, and he was treated with oral antibiotics (brand unknown).The end user stated there was no sharpness to the flange, but it was under pressure from the bend in his abdomen.He further stated that there was leakage under the flange which he felt contributed to the skin breakdown.The end user reported the ulcer is now healed.No photos are available, nor has any additional information been provided.

• Brand Name: NATURA
• Type of Device: PROTECTOR, OSTOMY
• MDR Report Key: 6652169
• MDR Text Key: 77914020
• Report Number: 1049092-2017-00033
• Device Sequence Number: 1
• Product Code: EXE
• Combination Product (y/n): N
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 404594
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR