RIGIDLOOP DISPOSABLES SYSTM 232037

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2019-10-08 for RIGIDLOOP DISPOSABLES SYSTM 232037 manufactured by Medos International Sàrl.

MAUDE Entry Details

Report Number1221934-2019-58867
MDR Report Key9169077
Report SourceCOMPANY REPRESENTATIVE,OTHER
Date Received2019-10-08
Date of Report2019-09-12
Date of Event2019-09-12
Date Mfgr Received2019-10-24
Device Manufacturer Date2019-05-08
Date Added to Maude2019-10-08
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 ContactKARA DITTY-BOVARD
Manufacturer StreetRAYNHAM
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MEDOS INTERNATIONAL SàRL
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal Code02400
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRIGIDLOOP DISPOSABLES SYSTM
Generic NameORTHOPAEDIC SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE-USE
Product CodeKDD
Date Received2019-10-08
Catalog Number232037
Lot Number4L35088
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-08

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