RUSCH EQUIPLED BLADEMAC 3 5843

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-27 for RUSCH EQUIPLED BLADEMAC 3 5843 manufactured by Teleflex Medical.

Event Text Entries

[188680767] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[188680768] Customer complaint alleges "very difficult to put the blade on the handle and some times it is not possible at all" prior to intubation. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8030121-2020-00077
• MDR Report Key: 9891869
• Report Source: DISTRIBUTOR,FOREIGN
• Date Received: 2020-03-27
• Date of Report: 2020-03-25
• Date of Event: 2020-02-19
• Date Mfgr Received: 2020-03-25
• Date Added to Maude: 2020-03-27
• 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: VICTORIA SANDLIN
• Manufacturer Street: 3015 CARRINGTON MILL BLVD
• Manufacturer City: MORRISVILLE NC 27560
• Manufacturer Country: US
• Manufacturer Postal: 27560
• Manufacturer G1: TRUPHATEK INTERNATIONAL LTD.
• Manufacturer Street: 14 BENNY GAON STREET P.O. 8051
• Manufacturer City: NETANYA 4250443
• Manufacturer Country: IS
• Manufacturer Postal Code: 4250443
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RUSCH EQUIPLED BLADEMAC 3
• Generic Name: LARYNGOSCOPE, RIGID
• Product Code: CCW
• Date Received: 2020-03-27
• Catalog Number: 5843
• Lot Number: 171001
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL
• Manufacturer Address: ATHLONE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-27