MODUTEC 84023483

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for MODUTEC 84023483 manufactured by Maquet Sas.

Event Text Entries

[183487875] Additional information will be provided upon results of investigation. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[183487876] On (b)(6) 2017 getinge became aware about customer allegation related to end cap and silver metal cap which fell off from the modutec device. There is no information about patient involvement, however we decided to report this case in abundance of caution as any parts falling down into sterile field might led to contamination. Manufacturer's reference number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9710055-2020-00039
MDR Report Key9833795
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2017-04-26
Date Mfgr Received2017-04-26
Date Added to Maude2020-03-16
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 ContactMR. PASCAL JAY
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Manufacturer G1MAQUET SAS
Manufacturer StreetPARC DE LIMERE AVENUE DE LA POMME DE PIN
Manufacturer CityARDON
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMODUTEC
Generic NameLIGHT, SURGICAL, CEILING MOUNTED
Product CodeFSY
Date Received2020-03-16
Catalog Number84023483
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET SAS
Manufacturer AddressPARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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