FOUNDATION 27-500-100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-19 for FOUNDATION 27-500-100 manufactured by Olympus Terumo Biomaterials Corp. Mishima Factory.

MAUDE Entry Details

• Report Number: 3007738819-2019-00005
• MDR Report Key: 9857968
• Report Source: HEALTH PROFESSIONAL,USER FACI
• Date Received: 2020-03-19
• Date of Report: 2019-05-04
• Date Mfgr Received: 2019-05-04
• Device Manufacturer Date: 2014-09-19
• 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: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JIRO HIRAI
• Manufacturer Street: 1-50-1 SASAZUKA,SHIBUYA-KU
• Manufacturer City: TOKYO, 151-0073
• Manufacturer Country: JA
• Manufacturer Postal: 151-0073
• Manufacturer G1: OLYMPUS TERUMO BIOMATERIALS CORP.
• Manufacturer Street: 1-50-1 SASAZUKA,SHIBUYA-KU
• Manufacturer City: TOKYO, 151-0073
• Manufacturer Country: JA
• Manufacturer Postal Code: 151-0073
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FOUNDATION
• Generic Name: BONE GRAFTING MATERIAL, SYNTHETIC
• Product Code: LYC
• Date Received: 2020-03-19
• Model Number: 27-500-100
• Catalog Number: 27-500-100
• Lot Number: M1407E
• Device Expiration Date: 2017-06-30
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY
• Manufacturer Address: 454-1 HIGASHINO,NAGAIZUMI-CHO SUNTO-GUN SHIZUOKA, 411-0931 JA 411-0931

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-19