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

Catalog Number 90620US

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

Patient Problems Headache (1880); Pain (1994)

Event Date 07/20/2019

Event Type  Injury  

Manufacturer Narrative

The device not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A physician reported and described that on (b)(6) 2019, the 90620us duo headlight 2 bay system ¿ us, caused pain on the top of his head where the padding of the duo headlight adjustment knob met on his head during a plastic surgery.The doctor reported that after wearing the device for one hour the pain was severe enough that he had to take the light off and that he developed a headache and felt a sore spot on his head for several hours afterwards.Attempts to refit the headlight on his head were made including using the fit guide, however, the issue did not resolve.Additional information has been requested.

Manufacturer Narrative

Additional information received on 17sep2019 and 09oct2019 reported that the headlight was uncomfortable, hurt the doctor¿s head and gave him a headache.The product was not returned for evaluation.Lot number/serial number not received to perform device history record review.A failure analysis and determination of root cause is not possible due to product has not been returned.The reported complaint is unconfirmed.Device identifier: (b)(4).

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Type of Device: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8928806
• MDR Text Key: 155486861
• Report Number: 2523190-2019-00102
• 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: 07/29/2019

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: 90620US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/25/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1