3612 LITE GLOVE 31140257

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for 3612 LITE GLOVE 31140257 manufactured by Covidien.

Event Text Entries

[60856075] Submit date: 11/21/2016. An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[60856076] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a light glove. The customer reports: the gloves have cuts right out of the package.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2016-00672
MDR Report Key6117049
Date Received2016-11-21
Date of Report2016-11-14
Date Mfgr Received2016-11-14
Date Added to Maude2016-11-21
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE ST
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3612 LITE GLOVE
Generic NameLIGHT GLOVE
Product CodeLYU
Date Received2016-11-21
Model Number31140257
Catalog Number31140257
Lot Number5204102364X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-21

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