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

Model Number	6.5PLC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/16/2017
Type of Reportable Event	Serious Injury
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 cuff was deflated so an emergency tracheostomy change was performed.It was reported that the defective product is unavailable.

• 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,cl 32590 ; MX 32590
• MDR Report Key: 7260731
• Report Number: 2936999-2018-00083
• Device Sequence Number: 16171087
• Product Code: JOH
• UDI-Device Identifier: 20884522029060
• UDI-Public: 20884522029060
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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 Model Number: 6.5PLC
• Device Catalogue Number: 6.5PLC
• Device Lot Number: 16C0684JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: Required Intervention
• Patient Age: 7 YR