STICK SPONGE PVP PAINT 41550

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-02-02 for STICK SPONGE PVP PAINT 41550 manufactured by Covidien.

Event Text Entries

[2495303] It was reported to covidien on (b)(6) 2012 that a customer had an issue with a pvp stick sponge. The customer reported that the sponge came off the stick prior to use.
Patient Sequence No: 1, Text Type: D, B5


[9654927] Submit date (b)(4) 2012. An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2012-00006
MDR Report Key2463636
Report Source05,06,07
Date Received2012-02-02
Date of Report2012-01-06
Report Date2012-01-06
Date Reported to Mfgr2012-01-06
Date Mfgr Received2012-01-06
Date Added to Maude2012-08-13
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 ContactSHARON SELBY
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5082618488
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA 92173
Manufacturer CountryMX
Manufacturer Postal Code92173
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTICK SPONGE PVP PAINT
Generic NameSTICK SPONGE
Product CodeOJU
Date Received2012-02-02
Model Number41550
Catalog Number41550
Lot NumberUNKNOWN
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 TIJUANA 92173 MX 92173


Patients

Patient NumberTreatmentOutcomeDate
10 2012-02-02

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