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

Model Number	10FEN
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2020
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 device had cuff inflation/deflation issue.There was no patient involvement.

• 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: 10313383
• Report Number: 2936999-2020-00516
• Device Sequence Number: 3624115
• Product Code: JOH
• UDI-Device Identifier: 60884522006984
• UDI-Public: 60884522006984
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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 Expiration Date: 10/23/2023
• Device Model Number: 10FEN
• Device Catalogue Number: 10FEN
• Device Lot Number: 18J0599JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1