DISPOSABLE 1/2IN COLLECTION SET CASE BKT-506

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-03 for DISPOSABLE 1/2IN COLLECTION SET CASE BKT-506 manufactured by Seisa Medical Sales, Llc.

MAUDE Entry Details

Report Number2951238-2019-01136
MDR Report Key9151754
Report SourceUSER FACILITY
Date Received2019-10-03
Date of Report2019-10-03
Date of Event2019-09-05
Date Mfgr Received2019-09-05
Date Added to Maude2019-10-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDISPOSABLE 1/2IN COLLECTION SET CASE
Generic NameDISPOSABLE 1/2IN COLLECTION SET
Product CodeHHK
Date Received2019-10-03
Returned To Mfg2019-09-19
Model NumberBKT-506
Lot NumberS174615
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSEISA MEDICAL SALES, LLC
Manufacturer Address9005 MONTANA AVENUE EL PASO TX 79925 US 79925


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-03

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