MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; STYLET, TRACHEAL TUBE

Model Number 85865

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the guide for the orotracheal tube was very soft, and at the time of intubation it bended at an angle that made it difficult to direct the tube through the buccal cords.There was no reported patient outcome.

• Brand Name: SHILEY
• Type of Device: STYLET, TRACHEAL TUBE
• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 11515401
• MDR Text Key: 242952614
• Report Number: 2936999-2021-00240
• Device Sequence Number: 1
• Product Code: BSR
• UDI-Device Identifier: 10884522004091
• UDI-Public: 10884522004091
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: 85865
• Device Catalogue Number: 85865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR