MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; DEPRESSOR, TONGUE, NON-SURGICAL

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2016

Event Type  malfunction  

Event Description

During extubation, anesthesiologist noted tongue blade was broken and portion missing.

• Type of Device: DEPRESSOR, TONGUE, NON-SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 6120906
• MDR Text Key: 60679623
• Report Number: 6120906
• Device Sequence Number: 1
• Product Code: FMA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2016

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR