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

Model Number	4.0PEF
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Unintended Extubation (4564)
Date of Event	08/01/2020
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 patient is a chronic trach patient since the age of (b)(6) months and had been using a 4.0ped trach at home without incident.When hospitalized in august for a non-related infection, the patient had an underlying fever and was on antibiotics in the hospital at which time the trach was replaced with a 4.0pef.After two days of using the device, the patient had marked redness without breakdown on the neck around the area that came in contact with the trach flange.The trach was replaced with a 4.0ped and the redness cleared up quickly.Normal practice for this patient had been to use a 2x2 gauze pad under the flange.This practice did not change when the new trach was placed.

• 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: 11074763
• Report Number: 2936999-2020-00964
• Device Sequence Number: 16959037
• Product Code: JOH
• UDI-Device Identifier: 20884521101576
• UDI-Public: 20884521101576
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2020

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: 4.0PEF
• Device Catalogue Number: 4.0PEF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/28/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 9 YR