MAUDE Adverse Event Report: MITG - HENEQUEN SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	3.5NEF
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient had a rash for a couple of months.Tried ointments but it would not help.The rash was specifically at the trach area and was confirmed as contact dermatitis (rash is an angry red like a heat rash.No blisters).It was stated that the patient switched from white hub to clear hub and had an allergy since.The patient is ok but continues to get rashes localized to the trach site that caused discomfort.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MITG - HENEQUEN; avenida henequen; cd. juarez, chihuahua ; MX
• MDR Report Key: 11840953
• Report Number: 2936999-2021-00447
• Device Sequence Number: 19999254
• Product Code: JOH
• UDI-Device Identifier: 20884521779607
• UDI-Public: 20884521779607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.5NEF
• Device Catalogue Number: 3.5NEF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 11