MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMED; LARYNGOSCOPE

Model Number 3-01B7-01

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned nor were pictures supplied to further define how the handles light was not working.Without the device being returned or a clear understanding of what was causing the light to not illuminate, the investigation is inconclusive.

Event Description

The customer alleges the "light not working in handle''.No other details were provided and no patient injury/harm reported.

• Brand Name: EVALUMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 8697103
• MDR Text Key: 148148485
• Report Number: 1314417-2019-00036
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3-01B7-01
• Device Lot Number: RI
• Type of Device Usage: N
• Patient Sequence Number: 1