PENTAX CS-6021T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-06-25 for PENTAX CS-6021T manufactured by Hoya Corporation Pentax Tokyo Office.

MAUDE Entry Details

• Report Number: 9610877-2019-00345
• MDR Report Key: 8731802
• Report Source: FOREIGN
• Date Received: 2019-06-25
• Date of Report: 2019-06-10
• Date of Event: 2019-06-10
• Date Facility Aware: 2019-06-10
• Report Date: 2019-06-25
• Date Reported to FDA: 2019-06-25
• Date Reported to Mfgr: 2019-06-25
• Date Mfgr Received: 2019-06-10
• Date Added to Maude: 2019-06-25
• 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: MR. WILLIAM GOELLER (TEMPORARY)
• Manufacturer Street: 3 PARAGON DRIVE
• Manufacturer City: MONTVALE NJ 07645
• Manufacturer Country: US
• Manufacturer Postal: 07645
• Manufacturer Phone: 8004315880
• Manufacturer G1: HOYA CORPORATION PENTAX TOKYO OFFICE
• Manufacturer Street: TSUTSUJIGAOKA 1-1-110
• Manufacturer City: AKISHIMA-SHI, 196-0012
• Manufacturer Country: JA
• Manufacturer Postal Code: 196-0012
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PENTAX
• Generic Name: CLEANING BRUSH
• Product Code: MNL
• Date Received: 2019-06-25
• Model Number: CS-6021T
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOYA CORPORATION PENTAX TOKYO OFFICE
• Manufacturer Address: TSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI, 196-0012 JA 196-0012

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-06-25