NS-3600-B LITE GLOVE 1000/CASE 571711

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-06-30 for NS-3600-B LITE GLOVE 1000/CASE 571711 manufactured by Covidien.

Event Text Entries

[48556118] Submit date: 06/30/2016. An investigation is currently underway. Upon completion, the results will be forwarded. Several attempts to gather information from the customer were made. To date, no response has been received. If additional pertinent information becomes available, the report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[48556119] It was reported to covidien on 06/24/2016 that a customer had an issue with a lite glove. The customer reports light handle glove is splitting during the procedure.
Patient Sequence No: 1, Text Type: D, B5


[56178803] 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. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis. A corrective and preventative action (capa) has been opened to determine the root cause of this reported event. When root causes 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 Number9612030-2016-00300
MDR Report Key5761161
Report SourceDISTRIBUTOR
Date Received2016-06-30
Date of Report2016-06-24
Date Mfgr Received2016-09-29
Date Added to Maude2016-06-30
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 22500
Manufacturer CountryMX
Manufacturer Postal Code22500
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNS-3600-B LITE GLOVE 1000/CASE
Generic NameLITE GLOVE
Product CodeLZC
Date Received2016-06-30
Model Number571711
Catalog Number571711
Lot Number5341104364X
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressCALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX


Patients

Patient NumberTreatmentOutcomeDate
10 2016-06-30

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