MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT AND CARRYING CASE; PFM05

Model Number 90600

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

Patient Problem Headache (1880)

Event Date 07/11/2022

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

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.

Event Description

N/a.

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.

• Brand Name: DUO HEADLIGHT AND CARRYING CASE
• Type of Device: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15230946
• MDR Text Key: 297953269
• Report Number: 3006697299-2022-00111
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780491064
• UDI-Public: 10381780491064
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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 Model Number: 90600
• Device Catalogue Number: 90600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female