MALLINCKRODT 85864

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-07-11 for MALLINCKRODT 85864 manufactured by Mmj Sa De Cv (usd).

Event Text Entries

[79812311] (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[79812312] Medtronic received a report that 380 units of lot 16k0104jzx had a labeling issue. The reporter stated that the validity date is divergent between the packaging.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2017-05316
MDR Report Key6704837
Report SourceFOREIGN
Date Received2017-07-11
Date of Report2017-06-19
Date of Event2017-06-19
Date Mfgr Received2017-06-19
Device Manufacturer Date2016-11-01
Date Added to Maude2017-07-11
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 ContactSHARON MURPHY
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone2034925267
Manufacturer G1MMJ SA DE CV (USD)
Manufacturer StreetAVE HENEQUEN NO 1181 DESARROLL
Manufacturer CityCIUDAD JUAREZ 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALLINCKRODT
Generic NameSTYLET, TRACHEAL TUBE
Product CodeBSR
Date Received2017-07-11
Model Number85864
Catalog Number85864
Lot Number16K0104JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV (USD)
Manufacturer AddressAVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-11

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