SHANK #1 - 44.5MM 1702L 500 10 4 197 008 016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-09 for SHANK #1 - 44.5MM 1702L 500 10 4 197 008 016 manufactured by Ss White.

Event Text Entries

[62367844] Facility placed order for ss white carbide burs hp-1702l and 1703l. Per the flier showing the cc white bur product line, thought above products were sterile. Our facility requires these used in oral surgeries to be sterile. However, it was noticed just prior to using on a pt they are not sterile, but biologically clean. Felt the flier is very misleading.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5066647
• MDR Report Key: 6169192
• Date Received: 2016-12-09
• Date of Report: 2016-12-08
• Date of Event: 2016-12-02
• Date Added to Maude: 2016-12-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: SHANK #1 - 44.5MM 1702L
• Generic Name: SHANK #1 - 44.5MM 1702L
• Product Code: NDP
• Date Received: 2016-12-09
• Catalog Number: 500 10 4 197 008 016
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SS WHITE
• Manufacturer Address: 1145 TOWBIN AVE LAKEWOOD NJ 08701 US 08701

Device Sequence Number: 2

• Brand Name: 1703L CROSS CUT FISSURE ORAL SURGERY BUR
• Generic Name: 1703L CROSS CUT FISSURE ORAL SURGERY BUR
• Product Code: EBZ
• Date Received: 2016-12-09
• Catalog Number: 14915 500 10 4 197 008 021
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SS WHITE
• Manufacturer Address: 1145 TOWBIN AVE. LAKEWOOD NJ 08701 US 08701

Patients

Patient Number	Treatment	Outcome	Date
1	250		2016-12-09