• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Wound Dehiscence (1154)
Event Date 05/08/2020
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 (b)(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 system. One event alleges that a patient (on full anticoagulation due to factor v leiden genotype) developed a partial wound dehiscence after placement of a scout reflector and use of the savi scout system. The wound was sutured under local anaesthesia in the outpatient setting. Study: tayeh, salim, samantha muktar, jennifer heeney, michael j. Michell, nicholas perry, tamara suaris, david evans, anmol malhotra, and kefah mokbel. "reflector-guided localization of non-palpable breast lesions: the first reported european evaluation of the savi scout® system. " anticancer research 40, no. 7 (2020): 3915-3924.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12160288
MDR Text Key261296462
Report Number2032338-2021-00013
Device Sequence Number1
Product Code NEU
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K181007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,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
-
-