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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL - ALISO VIEJO SAVI; SYSTEM, APPLICATOR, TRAY
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MERIT MEDICAL - ALISO VIEJO SAVI; SYSTEM, APPLICATOR, TRAY Back to Search Results
Model Number 00884450434413
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/18/2020
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 during removal of the device, a part of it broke off.The device was surgically removed from the patient.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, 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, TRAY
Manufacturer (Section D)
MERIT MEDICAL - ALISO VIEJO
6 journey unit 125
aliso viejo CA 92656
MDR Report Key11132709
MDR Text Key225572895
Report Number2032338-2021-00001
Device Sequence Number1
Product Code JAQ
UDI-Device Identifier00884450434413
UDI-Public00884450434413
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 12/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00884450434413
Device Catalogue NumberSAVI-08GAMMA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Date Manufacturer Received01/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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