TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-06-28 for TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME 5000 manufactured by Sakura Finetek Usa, Inc..

MAUDE Entry Details

• Report Number: 2083544-2019-00002
• MDR Report Key: 8745155
• Report Source: DISTRIBUTOR,FOREIGN,USER FACI
• Date Received: 2019-06-28
• Date of Report: 2019-06-28
• Date of Event: 2019-06-06
• Date Mfgr Received: 2019-06-07
• Device Manufacturer Date: 2018-04-13
• Date Added to Maude: 2019-06-28
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SOLMAZ SHAIDA
• Manufacturer Street: 1750 WEST 214TH STREET
• Manufacturer City: TORRANCE 90501
• Manufacturer Country: US
• Manufacturer Postal: 90501
• Manufacturer Phone: 3109727800
• Manufacturer G1: SAKURA FINETEK USA, INC.
• Manufacturer Street: 1750 WEST 214TH STREET
• Manufacturer City: TORRANCE CA 90501
• Manufacturer Country: US
• Manufacturer Postal Code: 90501
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TISSUE-TEK AUTOSECTION(R) AUTOMATED MICROTOME
• Generic Name: AUTOSECTION
• Product Code: IDO
• Date Received: 2019-06-28
• Catalog Number: 5000
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SAKURA FINETEK USA, INC.
• Manufacturer Address: 1750 WEST 214TH STREET TORRANCE CA 90501 US 90501

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-06-28