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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL - ALISO VIEJO SCOUT MARKER, RADIOGRAPHIC, IMPLANTABLE

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MERIT MEDICAL - ALISO VIEJO SCOUT MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number SSR75-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 07/05/2019
Event Type  Injury  
Manufacturer Narrative
The suspect device was not returned for evaluation. The complaint could not be confirmed. The root cause could not be determined. A review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event Description
On april 6, 2021, a merit employee conducted a cer literature search for the scout product family. The study (see citation below) reports adverse events related to the savi scout radar. One event alleges that a patient developed an infection after placement of a scout reflector. Study: srour, marissa k. , sungjin kim, farin amersi, armando e. Giuliano, and alice chung. "comparison of wire localization, radioactive seed, and savi scout® radar for management of surgical breast disease. " the breast journal 26, no. 3 (2020): 406-413.
 
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Brand NameSCOUT
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
MERIT MEDICAL - ALISO VIEJO
6 journey unit 125
aliso viejo CA 92656
Manufacturer (Section G)
MERIT MEDICAL - ALISO VIEJO
6 journey unit 125
aliso viejo CA 92656
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
8012084662
MDR Report Key12160290
MDR Text Key261296289
Report Number2032338-2021-00010
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSSR75-01
Device Catalogue NumberSSR75-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2021
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 Treatment Data
Date Received: 07/13/2021 Patient Sequence Number: 1
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