2-6235 KERLIX LAP SPG D/W

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 2020-03-05 for 2-6235 KERLIX LAP SPG D/W manufactured by Covidien.

Event Text Entries

[183122800] The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.? If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10


[183122801] The customer reported that during an intervention, it was noticed that the sponge count was 6 instead of 5 as advertised on the box.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2020-00407
MDR Report Key9793656
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-03-31
Date of Event2020-01-30
Date Mfgr Received2020-02-28
Date Added to Maude2020-03-05
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street1430 MARVIN GRIFFIN ROAD, PO B
Manufacturer CityAUGUSTA GA 30906
Manufacturer CountryUS
Manufacturer Postal Code30906
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2-6235 KERLIX LAP SPG D/W
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2020-03-05
Model Number2-6235
Catalog Number2-6235
Lot Number19G027462
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address1430 MARVIN GRIFFIN ROAD, PO B AUGUSTA GA 30906 US 30906


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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