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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS SAVI; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
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MERIT MEDICAL SYSTEMS SAVI; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED Back to Search Results
Model Number 00884450434239
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that while placed the savi with a trocar, the patient experienced significant bleeding.The procedure has to be stopped and the savi was not placed.No patient harm to report and the bleeding has been stopped.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
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Brand Name
SAVI
Type of Device
SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS
6 journey unit 125
aliso viejo CA 92656
MDR Report Key11596293
MDR Text Key243168697
Report Number2032338-2021-00003
Device Sequence Number1
Product Code JAQ
UDI-Device Identifier00884450434239
UDI-Public00884450434239
Combination Product (y/n)N
PMA/PMN Number
K081677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/09/2022
Device Model Number00884450434239
Device Catalogue NumberSAVI-06/B
Device Lot NumberH1966320
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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