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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SSCOR INC. S-SCORT II

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SSCOR INC. S-SCORT II Back to Search Results
Model Number 15006
Device Problem No Apparent Adverse Event
Event Date 07/11/2019
Event Type  Malfunction  
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Brand NameS-SCORT II
Type of DeviceS-SCORT II
Manufacturer (Section D)
11064 randall st.
sun valley CA 91352
Manufacturer (Section G)
11064 randall st.
sun valley CA 91352
Manufacturer Contact
maira ojeda
11064 randall st.
sun valley , CA 91352
MDR Report Key8903900
Report Number2022724-2019-00005
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number15006
Device Catalogue Number15006
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/23/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/04/2004
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown