DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-07-12 for DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001 manufactured by Integra Lifesciences Corp.

MAUDE Entry Details

• Report Number: 3003418325-2019-00023
• MDR Report Key: 8785678
• Report Source: FOREIGN,USER FACILITY
• Date Received: 2019-07-12
• Date of Report: 2019-06-28
• Date of Event: 2019-04-29
• Date Mfgr Received: 2019-09-19
• Device Manufacturer Date: 2018-08-29
• Date Added to Maude: 2019-07-12
• 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: MRS. KIMBERLY SHELLY
• Manufacturer Street: 311 ENTERPRISE DRIVE
• Manufacturer City: PLAINSBORO NJ 08536
• Manufacturer Country: US
• Manufacturer Postal: 08536
• Manufacturer Phone: 6099362319
• Manufacturer G1: INTEGRA LIFESCIENCES CORP
• Manufacturer Street: 311 ENTERPRISE DRIVE
• Manufacturer City: PLAINSBORO NJ 08536
• Manufacturer Country: US
• Manufacturer Postal Code: 08536
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED
• Generic Name: DURASEAL SPINE
• Product Code: NQR
• Date Received: 2019-07-12
• Returned To Mfg: 2019-08-21
• Catalog Number: 203001
• Lot Number: N8HC891X
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA LIFESCIENCES CORP
• Manufacturer Address: 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-07-12