JAZZ 150156 350156

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-19 for JAZZ 150156 350156 manufactured by Implanet.

MAUDE Entry Details

• Report Number: 3007675554-2020-00001
• MDR Report Key: 9852259
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-19
• Date of Report: 2020-03-12
• Date of Event: 2020-02-11
• Date Facility Aware: 2020-02-11
• Report Date: 2020-03-12
• Date Reported to FDA: 2020-03-12
• Date Reported to Mfgr: 2020-02-11
• Date Mfgr Received: 2020-02-11
• Date Added to Maude: 2020-03-19
• 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. REGIS LE COUEDIC
• Manufacturer Street: TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE
• Manufacturer City: MARTILLAC, 33650, FR,
• Manufacturer Country: US
• Manufacturer G1: IMPLANET
• Manufacturer Street: TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRANCOIS MAGENDIE
• Manufacturer City: MARTILLAC, 33650, FR,
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: JAZZ
• Generic Name: JAZZ BAND
• Product Code: OWI
• Date Received: 2020-03-19
• Model Number: 150156
• Catalog Number: 350156
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IMPLANET
• Manufacturer Address: TECHNOPOLE BORDEAUX MONTESQUIE ALLEE FRAN?OIS MAGENDIE MARTILLAC, NOUVELLE AQUITAINE 33650 FR 33650

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-19