SITUATE 01-0043

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-02-26 for SITUATE 01-0043 manufactured by Covidien Mfg Dc Boulder.

Event Text Entries

[181659095] This product is not sold in us and is 510(k) exempt. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[181659096] According to the reporter, when the device was used to scan for sponges, the scanner kept on reading positive 2 times. They took 2 x-rays and it showed that there was no sponges. They tried 4 more times with the scanner and the result was clear each time, showing there was no sponges.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1717344-2020-00192
MDR Report Key9753583
Report SourceCONSUMER,USER FACILITY
Date Received2020-02-26
Date of Report2020-02-28
Date Mfgr Received2020-01-31
Date Added to Maude2020-02-26
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 ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN MFG DC BOULDER
Manufacturer Street5920 LONGBOW DR
Manufacturer CityBOULDER CO 803013299
Manufacturer CountryUS
Manufacturer Postal Code803013299
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSITUATE
Generic NameCOUNTER, SPONGE, SURGICAL
Product CodeLWH
Date Received2020-02-26
Model Number01-0043
Catalog Number01-0043
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN MFG DC BOULDER
Manufacturer Address5920 LONGBOW DR BOULDER CO 803013299 US 803013299


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-26

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