TRAY WET SKIN SCRB/SM WING SPG 41589

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2009-02-05 for TRAY WET SKIN SCRB/SM WING SPG 41589 manufactured by Covidien.

Event Text Entries

[1040210] It was reported to covidien in 2009 that a customer had an issue with a wet skin scrub kit. The customer stated that the sponge used to prep the inside of the vagina is coming off of the stick.
Patient Sequence No: 1, Text Type: D, B5


[8166979] An investigation is currently underway, upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2009-00005
MDR Report Key1309687
Report Source06,07
Date Received2009-02-05
Date of Report2009-01-28
Report Date2009-01-28
Date Reported to Mfgr2009-01-28
Date Mfgr Received2009-01-28
Date Added to Maude2009-05-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location3
Manufacturer ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524970
Manufacturer G1COVIDIEN
Manufacturer Street9255 CUSTOMHOUSE PLAZA SUITE A
Manufacturer CitySAN DIEGO CA 92173
Manufacturer CountryUS
Manufacturer Postal Code92173
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRAY WET SKIN SCRB/SM WING SPG
Generic NameWET SKIN SCRUB TRAY
Product CodeGEC
Date Received2009-02-05
Model Number41589
Catalog Number41589
Lot Number819986264
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address9255 CUSTOMHOUSE PLAZA SAN DIEGO CA 92173 US 92173


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-05

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