SUPERDIMENSION AAS00161-20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for SUPERDIMENSION AAS00161-20 manufactured by Covidien Lp - Superdimension Inc.

Event Text Entries

[189082885] Out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[189082886] According to the reporter during a procedure, the device had a divergence, the physician was not able to complete the enb portion of the case nor was it completed by other means. The patient is under general anesthesia.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004962788-2020-00017
MDR Report Key9862457
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-11-22
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityMINNEAPOLIS MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1COVIDIEN LP - SUPERDIMENSION INC
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal Code55441
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERDIMENSION
Generic NameSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product CodeJAK
Date Received2020-03-20
Model NumberAAS00161-20
Catalog NumberAAS00161-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP - SUPERDIMENSION INC
Manufacturer Address161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-20

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