DUO HEADLIGHT AND CARRYING CASE
Received Aug 16, 2022 · Event occurred Jul 11, 2022
Report 3006697299-2022-00111 · MDR key 15230946
Device
Generic name
Pfm05
Manufacturer
Integra Lifesciences (ireland) Ltd.Model number
90600Catalog number
90600
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Headache
- Headache
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT THE DUO HEADLIGHT (90600) WAS TOO UNCOMFORTABLE FOR THE SURGEON. SHE TRIED FOR THREE DAYS AND THE HEADLIGHT GAVE HER SEVERE HEADACHES. THERE WAS NO REPORTED PATIENT INJURY AND NO DELAY IN SURGERY REPORTED.
Description of Event or Problem
N/A
Additional Manufacturer Narrative
UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H10 THE DUO HEADLIGHT AND CARRYING CASE (90600) WAS RETUNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): DHR SHOWS NO ABNORMALITIES RELATED TO THE REPORTED ISSUE. VISUAL/FUNCTIONAL EVALUATION OF THE DUO HEADLIGHT NOTED THAT THE UNIT WAS IN USED CONDITION WITH NO VISIBLE DEFECT. THE HEADLIGHT WAS WITHIN SPECIFICATIONS AND FUNCTIONED AS INTENDED. THE ADJUSTMENT WORKED PROPERLY. THE ISSUE OF HEADACHES COULD NOT BE DUPLICATED. THIS COMPLAINT MAY BE THE RESULT OF USER/CUSTOMER PREFERENCE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION IS REQUIRED BASED ON THE ACCEPTABILITY OF RISK. THIS ISSUE WILL BE MONITORED AND TRENDED GOING FORWARD.