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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CANADA, INC. COIL EMBL 8CM 3MM AZUR CX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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TERUMO MEDICAL CANADA, INC. COIL EMBL 8CM 3MM AZUR CX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 45-780308
Device Problem Nonstandard Device (1420)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2020
Event Type  malfunction  
Event Description
My mom, (b)(6) was a patient at (b)(6) beginning (b)(6) 2020 when recalled products were implanted.Here's the product info: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=178674.The following products are on the recall list and were implanted: model number:45-780308 model number:45-780204 model number:45-780202.Various implants after a motor vehicle accident.Please inquire for list of other implants, explants and those lot numbers.Reference reports: mw5119048, mw5119050.
 
Event Description
My mom, (b)(6) was a patient at (b)(6) beginning (b)(6) 2020 when recalled products were implanted.Here's the product info: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=178674.The following products are on the recall list and were implanted: model number:45-780308 model number:45-780204 model number:45-780202.Various implants after a motor vehicle accident.Please inquire for list of other implants, explants and those lot numbers.Reference reports: mw5119048, mw5119050.
 
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Brand Name
COIL EMBL 8CM 3MM AZUR CX
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
TERUMO MEDICAL CANADA, INC.
MDR Report Key17247054
MDR Text Key318395977
Report NumberMW5119049
Device Sequence Number1
Product Code KRD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number45-780308
Device Lot Number1911145Z8
Was Device Available for Evaluation? No
Patient Sequence Number1
Patient Age80 YR
Patient SexFemale
Patient Weight79 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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