UNKNOWN LAP SPONGE

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 2020-03-13 for UNKNOWN LAP SPONGE manufactured by Mitg - Rf Surgical Systems.

Event Text Entries

[188412417] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188412418] According to the reporter, the gauze was linting as soon as it came out of the package. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005883396-2020-00021
MDR Report Key9831557
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-02-26
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-13
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 ContactLISA HERNANDEZ
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone2034925563
Manufacturer G1MITG - RF SURGICAL SYSTEMS
Manufacturer Street2101 FARADAY
Manufacturer CityCARLSBAD CA 92008
Manufacturer CountryUS
Manufacturer Postal Code92008
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN LAP SPONGE
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2020-03-13
Model NumberUNKNOWN LAP SPONGE
Catalog NumberUNKNOWN LAP SPONGE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMITG - RF SURGICAL SYSTEMS
Manufacturer Address2101 FARADAY CARLSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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