CAVIWIPE1 XL 12/CS 13-5150

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for CAVIWIPE1 XL 12/CS 13-5150 manufactured by Metrex Research.

Event Text Entries

[114279052] It was reported that the two employees reported to employee health to be seen and evaluated. Complainant has been contacted multiple times for further information, but has remained unresponsive no further information available. No patient information was provided in regards to age, weight, ethnicity and race. Date of event was not provided. No information was provided in regards to lot number, therefore device manufacturing date could not be determined. The product involved in the alleged incident was not returned and no lot number was provided; therefore no further evaluation could be done.
Patient Sequence No: 1, Text Type: N, H10


[114279053] A healthcare facility reported that two employees are suffering respiratory illness congestion and headaches which caused an asthmatic attack. The first employee developed a headache. The second employee had congestion and a headache.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722021-2018-00002
MDR Report Key7696318
Date Received2018-07-17
Date of Report2018-07-17
Date Mfgr Received2018-07-17
Date Added to Maude2018-07-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PAULO CALLE
Manufacturer Street1717 W COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167752
Manufacturer G1METREX RESEARCH
Manufacturer Street28210 WICK ROAD
Manufacturer CityROMULUS MI 48174
Manufacturer CountryUS
Manufacturer Postal Code48174
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCAVIWIPE1 XL 12/CS
Generic NameSURFACE DISINFECTANT
Product CodeLRJ
Date Received2018-07-17
Catalog Number13-5150
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMETREX RESEARCH
Manufacturer Address28210 WICK ROAD ROMULUS MI 48174 US 48174


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-07-17

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