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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERATHON MEDICAL ULC. MAC T3; VIDEO LARYNGOSCOPE
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VERATHON MEDICAL ULC. MAC T3; VIDEO LARYNGOSCOPE Back to Search Results
Model Number MAC T3
Device Problem Material Frayed (1262)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2015
Event Type  malfunction  
Event Description
The mac t3 device was discovered to have a sharp edge on the trip.Contact has no other information, no patient harm reported.
 
Manufacturer Narrative
Device evaluation summary: could not find any sharp edge near tip or anywhere else on the blade.On 05/10/2013 safety alert notice c/r 3022472-5-07-2013-0001-c was issued to all customers to provide additional safety information to remind users to carefully examine blades before and after each use, and promptly replace any that show signs of wear or damage.
 
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Brand Name
MAC T3
Type of Device
VIDEO LARYNGOSCOPE
Manufacturer (Section D)
VERATHON MEDICAL ULC.
burnaby, ca-bc
CA 
Manufacturer Contact
brian anderson
20001 north creek parkway
bothell, WA 98011
8003312313
MDR Report Key4951744
MDR Text Key17591054
Report Number9615393-2015-00057
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMAC T3
Device Catalogue Number0574-0128
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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