CURITY 6939-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-06 for CURITY 6939- manufactured by Covidien.

Event Text Entries

[110334319] 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.? If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[110334320] Customer reported the item was missing 1 in the pack of ten.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2018-00072
MDR Report Key7573526
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-06-06
Date of Report2018-06-06
Date Mfgr Received2018-06-04
Date Added to Maude2018-06-06
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 Street1647 PERKINS RD
Manufacturer CityAUGUSTA GA 30913
Manufacturer CountryUS
Manufacturer Postal Code30913
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCURITY
Generic NameFIBER, MEDICAL, ABSORBENT
Product CodeFRL
Date Received2018-06-06
Model Number6939-
Catalog Number6939-
Lot Number17J096462
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address1647 PERKINS RD AUGUSTA GA 30913 US 30913


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-06

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