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

Model Number	4.0PED
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/09/2018
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 device had a damaged fastening flap.The customer reported that the patient presented extreme bradycardia.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7922674
• Report Number: 2936999-2018-00620
• Device Sequence Number: 13849558
• Product Code: JOH
• UDI-Device Identifier: 30884522026714
• UDI-Public: 30884522026714
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Expiration Date: 03/28/2021
• Device Model Number: 4.0PED
• Device Catalogue Number: 4.0PED
• Device Lot Number: 16C0824JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/01/2018
• 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: Other
• Patient Age: 1 YR
• Patient Weight: 9