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 2016-08-05 for 3612 LITE GLOVE 31140257 manufactured by Covidien.

Event Text Entries

[52422432] Submit date: 08/05/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[52422433] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer reports the light glove split when placed on the operating room light. The customer further stated that the lite glove is a little tight when placing on the handle, they have to continually (shove) it on the handle and is a little more challenging than before. The split/tear was found mostly when placing on the handle during setup. Once the split was noticed they would remove the top glove if they double glove, and if they single glove, they change the glove. The customer states that the material is really thin. A skytron aurora adapter is being used with the lite glove.
Patient Sequence No: 1, Text Type: D, B5


[56217734] Submit date: 09/29/2016.
Patient Sequence No: 1, Text Type: N, H10


[57599900] Submit date: 09/29/2016. Originally reported as ns-3600-b lite glove 1000/case and should be 3612 lite glove. Model number: originally reported as unknown or and should be 31140257. Catalog number: originally reported as unknown or and should be 31140257. Lot number: originally left blank and per the product received from the customer, the lot number is 6147100264.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2016-00366
MDR Report Key5850318
Date Received2016-08-05
Date of Report2016-07-22
Date Mfgr Received2016-09-29
Date Added to Maude2016-08-05
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 CodeLYZ
Date Received2016-08-05
Model Number31140257
Catalog Number31140257
Lot Number6147100264
OperatorHEALTH PROFESSIONAL
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 2016-08-05

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