DROPSAFE UNKNOWN 8162

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-24 for DROPSAFE UNKNOWN 8162 manufactured by Htl-strefa S.a..

MAUDE Entry Details

Report Number9613304-2020-00009
MDR Report Key9872329
Report SourceCONSUMER
Date Received2020-03-24
Date of Report2020-02-26
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMRS. ALEKSANDRA PRAZMOWSKA-WILANOWSKA
Manufacturer StreetADAMOWEK 7
Manufacturer CityOZORKOW, 95-035
Manufacturer CountryPL
Manufacturer Postal95-035
Manufacturer G1HTL-STREFA S.A.
Manufacturer StreetADAMOWEK 7
Manufacturer CityOZORKOW, 95-035
Manufacturer CountryPL
Manufacturer Postal Code95-035
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDROPSAFE
Generic NameSAFETY PEN NEEDLE
Product CodeFMI
Date Received2020-03-24
Model NumberUNKNOWN
Catalog Number8162
Lot NumberUNKNOWN
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHTL-STREFA S.A.
Manufacturer AddressADAMOWEK 7 OZORKOW, 95-035 PL 95-035


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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