3611 LITE GLOVE 31140208

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 2016-06-13 for 3611 LITE GLOVE 31140208 manufactured by Covidien.

Event Text Entries

[47237683] Submit date: 06/13/2016. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[47237684] It was reported to covidien on (b)(6) 2016 that a customer had an issue with a lite glove. The customer states that the product is breaking.
Patient Sequence No: 1, Text Type: D, B5


[58739081] Submit date: 10/19/2016. The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. One case of samples with original packaging was received and the reported issue was not confirmed; none of the samples presents the reported condition. A corrective and preventative action (capa) has been opened to determine the root cause of this reported event. When root cause(s) is determined the appropriate actions will be taken to address the reported condition. If additional information is received this complaint will be reopened. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612030-2016-00284
MDR Report Key5720056
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2016-06-13
Date of Report2016-06-09
Date Mfgr Received2016-10-19
Device Manufacturer Date2015-05-19
Date Added to Maude2016-06-13
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 92173
Manufacturer CountryMX
Manufacturer Postal Code92173
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3611 LITE GLOVE
Generic NameLITE GLOVE
Product CodeLZC
Date Received2016-06-13
Model Number31140208
Catalog Number31140208
Lot Number5132100764X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.