OXYSEPT OXYTC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-10-28 for OXYSEPT OXYTC manufactured by Johnson & Johnson Surgical Vision, Inc..

MAUDE Entry Details

• Report Number: 3004178847-2019-00012
• MDR Report Key: 9243475
• Report Source: CONSUMER,FOREIGN,HEALTH PROFE
• Date Received: 2019-10-28
• Date of Report: 2019-10-27
• Date of Event: 2019-09-26
• Report Date: 2005-01-01
• Date Reported to FDA: 2005-01-01
• Date Reported to Mfgr: 2005-01-10
• Date Mfgr Received: 2019-09-26
• Device Manufacturer Date: 2018-11-06
• Date Added to Maude: 2019-10-28
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: SOMYATA NAGPAL
• Manufacturer Street: 1700 EAST ST. ANDREW PLACE
• Manufacturer City: SANTA ANA CA 92705
• Manufacturer Country: US
• Manufacturer Postal: 92705
• Manufacturer Phone: 7142478200
• Manufacturer G1: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Street: 4TH AVE HZ ECON/TECH DEVELOP. ZONE
• Manufacturer City: HANGZHOU 310018
• Manufacturer Country: CN
• Manufacturer Postal Code: 310018
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OXYSEPT
• Generic Name: ACCESSORIES
• Product Code: LPN
• Date Received: 2019-10-28
• Model Number: OXYTC
• Lot Number: ZE04472
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Manufacturer Address: 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-10-28