3612 LITE GLOVE 31140257

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-17 for 3612 LITE GLOVE 31140257 manufactured by Covidien.

Event Text Entries

[57576351] Submit date: 10/17/2016. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[57576352] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports it was noted that the light handle cover has inconsistent material throughout the product. It is thin and flimsy causing product to tear/split when used. There was a patient involved and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2016-00525
MDR Report Key6033108
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-10-17
Date of Report2017-11-16
Date of Event2016-09-22
Date Mfgr Received2016-09-26
Date Added to Maude2016-10-17
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 STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer StreetCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL
Manufacturer CityTIJUANA
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3612 LITE GLOVE
Generic NameLITE GLOVE
Product CodeLYU
Date Received2016-10-17
Model Number31140257
Catalog Number31140257
Lot Number6169100264
Device AvailabilityY
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2016-10-17

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