MAUDE Adverse Event Report: DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Catalog Number 90620US

Device Problem Defective Device (2588)

Patient Problem Headache (1880)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the duo headlight was used for a spinal decompression on (b)(6) 2020.The surgeon started getting headache 30 minutes into the case and used the unit for a total of one (1) hour before having to take off and adjust to a thinner 1.5 led padding with no improvement.The surgeon said that the padding in front was pressing against his temples just above his eyebrows and thought that the duo balance was more front loaded feeling like the headlight would continue to come forward.The surgeon rated his headache as 7 from a scale of 1 to 10, and felt better when he took off the duo headlight.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Duo headlight was not returned (customer declined to return the product for failure analysis); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Type of Device: PFM05
• MDR Report Key: 10852425
• MDR Text Key: 216627702
• Report Number: 2523190-2020-00135
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90620US
• Device Lot Number: L000266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/24/2020
• Date Device Manufactured: 04/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1