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

Model Number	M5.0PDL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/01/2021
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, one of the pamphlets on the device stated it was for single use only, not to clean or use it over 29 days due to the dehp.The patient was allergic to many things and had problems with eyes swelling up when the device was used.A different brand was used by the patient for 30 years without problem but it was no longer manufactured and had to use our device.Switching to a different one was not possible because no one would make a custom trach out of pvc.The customer tried to use the only custom trach in the country that was made from silicon bivona but the patient died.It was found out the patient was highly allergic to silicon.

• 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: 12069709
• Report Number: 2936999-2021-00619
• Device Sequence Number: 4765121
• Product Code: JOH
• UDI-Device Identifier: 10884521554672
• UDI-Public: 10884521554672
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K945513
• 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): 06/25/2021

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 Model Number: M5.0PDL
• Device Catalogue Number: M5.0PDL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1