ALARA ACCESS NEEDLE AAN-09-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-06 for ALARA ACCESS NEEDLE AAN-09-S manufactured by Surgentec, Llc.

MAUDE Entry Details

• Report Number: 3012495575-2019-00001
• MDR Report Key: 8674831
• Date Received: 2019-06-06
• Date of Report: 2019-05-31
• Date of Event: 2019-02-26
• Date Facility Aware: 2019-02-26
• Report Date: 2019-02-26
• Date Reported to Mfgr: 2019-02-26
• Date Mfgr Received: 2019-02-26
• Device Manufacturer Date: 2018-11-13
• Date Added to Maude: 2019-06-06
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. STEPHEN INGLESE
• Manufacturer Street: 7601 N FEDERAL HWY #150A
• Manufacturer City: BOCA RATON FL 33487
• Manufacturer Country: US
• Manufacturer Postal: 33487
• Manufacturer Phone: 5619907882
• Manufacturer G1: SURGENTEC, LLC
• Manufacturer Street: 7601 N FEDERAL HWY #150A
• Manufacturer City: BOCA RATON FL 33487
• Manufacturer Country: US
• Manufacturer Postal Code: 33487
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ALARA ACCESS NEEDLE
• Generic Name: GUIDE, NEEDLE, SURGICAL
• Product Code: GDF
• Date Received: 2019-06-06
• Model Number: ALARA ACCESS NEEDLE
• Catalog Number: AAN-09-S
• Lot Number: 1320
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 4 MO
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SURGENTEC, LLC
• Manufacturer Address: 7601 N FEDERAL HWY #150A BOCA RATON FL 33487 US 33487

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-06