OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES DCYL740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-08-06 for OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES DCYL740 manufactured by Pinnacle Biologics, Inc..

MAUDE Entry Details

• Report Number: 3010119152-2019-00002
• MDR Report Key: 8866481
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-08-06
• Date of Report: 2019-08-06
• Date of Event: 2017-11-02
• Date Mfgr Received: 2018-02-02
• Device Manufacturer Date: 2016-01-22
• Date Added to Maude: 2019-08-06
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 2801 LAKESIDE DR., SUITE 210
• Manufacturer City: BANNOCKBURN IL 60015
• Manufacturer Country: US
• Manufacturer Postal: 60015
• Manufacturer Phone: 8472837902
• Manufacturer G1: PIONEER OPTICS CO.
• Manufacturer Street: 35 GRIFFIN RD. SOUTH
• Manufacturer City: BLOOMFIELD CT 06002
• Manufacturer Country: US
• Manufacturer Postal Code: 06002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES
• Generic Name: FIBER OPTIC DIFFUSER
• Product Code: MVG
• Date Received: 2019-08-06
• Model Number: DCYL740
• Catalog Number: DCYL740
• Lot Number: 5662301
• Device Expiration Date: 2018-01-22
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PINNACLE BIOLOGICS, INC.
• Manufacturer Address: 2801 LAKESIDE DR., SUITE 210 BANNOCKBURN IL 60015 US 60015

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-08-06