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

Model Number	6IC75
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Dyspnea (1816); Unintended Extubation (4564)
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, during use, the inner component of the device was coated with ¿rubber cement like goop".The patient could not breathe right in three hours or less.Excessive force was required to get the inner part of the device pulled out.

• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: tanja beshear ; 5920 longbow drive; boulder, CO 80301 ; 3035306434
• MDR Report Key: 15070671
• Report Number: 2936999-2022-00650
• Device Sequence Number: 4773079
• Product Code: JOH
• UDI-Device Identifier: 10884521511958
• UDI-Public: 10884521511958
• Combination Product (Y/N): N
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2022

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: 11/06/2023
• Device Model Number: 6IC75
• Device Catalogue Number: 6IC75
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown