MAUDE Adverse Event Report: DUO HEADLIGHT AND CARRYING CASE; PFM05

Catalog Number 90600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994)

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 that they are unhappy with the comfort of the duo headlights (90600) as they are causing pain and headaches.When they remove the front pad, it feels a lot better.No delay in procedure was reported.

Manufacturer Narrative

Duo headlight (90600) was not returned for evaluation (customer stated that the product will not be returned) and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.This issue may be the result of customer preference.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 AND CARRYING CASE
• Type of Device: PFM05
• MDR Report Key: 11376571
• MDR Text Key: 233446724
• Report Number: 2523190-2021-00037
• 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: 04/08/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/08/2021
• 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