CURITY 3968

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-02-27 for CURITY 3968 manufactured by Covidien.

Event Text Entries

[68416402] An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[68416403] The customer reports we have a whole bunch of these gauze dressings where the product is sticking out of and part of the product is sealed in the seal. We had to open 4 or 5 today for one patient to get a sterile pack. Also, they are frayed on the edges and could leave part in the surgical site. No medical intervention required.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2017-05001
MDR Report Key6361279
Report SourceUSER FACILITY
Date Received2017-02-27
Date of Report2017-11-20
Date of Event2017-02-02
Date Mfgr Received2017-02-02
Device Manufacturer Date2016-09-30
Date Added to Maude2017-02-27
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 Received2017-02-27
Model Number3968
Catalog Number3968
Lot Number16J227762
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2017-02-27

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