MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 3; LARYNGOSCOPE, RIGID

Model Number IPN048418

Device Problem Sharp Edges (4013)

Patient Problem Laceration(s) (1946)

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported "miller 3 blade of trulite caused laceration on patients tongue".No serious injury or patient harm reported.No medical intervention reported.Patient condition reported as "fine".

Event Description

It was reported, "miller 3 blade of trulite caused laceration on patients tongue".No serious injury or patient harm reported.No medical intervention reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed.As it was reported, that the sample is not available for return.Without the device to evaluate, the complaint could not be confirmed.And the probable cause could not be determined, from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH TRULITE SECURE SU BLADE-HANDLE MILL 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12712488
• MDR Text Key: 278820140
• Report Number: 8030121-2021-00035
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704626172
• UDI-Public: 14026704626172
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN048418
• Device Catalogue Number: 004670003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1