INTEGRA? 90500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for INTEGRA? 90500 manufactured by Integra York Pa, Inc..

Event Text Entries

[176777267] An operating room patient care technician was setting up an operating room for a surgery that required use of a headlight. The integra headlight is used along with a battery pack that clips to the surgeon's waist. The patient care technician correctly identified the headlight and grabbed a cord he believed to be the connector between the headlight and battery pack as it looked the same. He brought the two components together and states there was a spark, smoke, and he dropped the two. The cord in fact belonged to a wall unit battery charger for another piece of equipment, the spider2.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9641375
• MDR Report Key: 9641375
• Date Received: 2020-01-29
• Date of Report: 2020-01-22
• Date of Event: 2020-01-19
• Report Date: 2020-01-22
• Date Reported to FDA: 2020-01-22
• Date Reported to Mfgr: 2020-01-29
• Date Added to Maude: 2020-01-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTEGRA?
• Generic Name: LIGHT, HEADBAND, SURGICAL
• Product Code: FSR
• Date Received: 2020-01-29
• Model Number: 90500
• Catalog Number: 90500
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK PA, INC.
• Manufacturer Address: 589 DAVIES DR YORK PA 17402 US 17402

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-29