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

Model Number	5.5PLC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information associated with the complaint has been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that a cuff was malformed.There was no patient injury.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• 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 ; MX
• MDR Report Key: 6462717
• Report Number: 2936999-2017-05112
• Device Sequence Number: 476255
• Product Code: JOH
• UDI-Device Identifier: 20884522029046
• UDI-Public: 20884522029046
• Combination Product (Y/N): N
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: 05/11/2021
• Device Model Number: 5.5PLC
• Device Catalogue Number: 5.5PLC
• Device Lot Number: 16E0315JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR