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 Erythema (1840); Headache (1880)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

The operating room manager of a facility reported that a surgeon was having a problem with the duo headlight (product id 90600) causing mild pain on his head; the surgeon stated that the headlight was uncomfortable and caused his head to hurt and created red marks on his forehead.The headlight was adjusted for comfort and the surgeon was instructed on how to wear the headlight.There was no further adverse event thereafter.

Manufacturer Narrative

90600 duo headlight and carrying case was not returned for evaluation 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.The reported issue was resolved by the product's adjustment knob.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.

Event Description

N/a.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• Type of Device: PFM05
• MDR Report Key: 11556623
• MDR Text Key: 241868936
• Report Number: 2523190-2021-00055
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

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: 02/24/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 04/06/2021
• 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