MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	10CFS
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report the cannula was difficult to remove off the patient.The customer did not disclose the patient outcome.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6827537
• Report Number: 2936999-2017-05428
• Device Sequence Number: 1431236
• Product Code: JOH
• UDI-Device Identifier: 60884522006946
• UDI-Public: 60884522006946
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2018
• Device Model Number: 10CFS
• Device Catalogue Number: 10CFS
• Device Lot Number: 13J0324JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other