2733 SPG GAUZE 4X4-16PLY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-25 for 2733 SPG GAUZE 4X4-16PLY manufactured by Covidien.

Event Text Entries

[134183737] Samples were received for evaluation without the customer reporting an issue for this product. Several requests for additional information from the the customer was unsuccessful. Upon sample analysis on 7-jan-2019 the product was found to be linting.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2019-00332
MDR Report Key8278604
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-01-25
Date of Report2019-02-12
Date Mfgr Received2019-01-07
Date Added to Maude2019-01-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
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 Phone5084524970
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 Name2733 SPG GAUZE 4X4-16PLY
Generic NameFIBER, MEDICAL, ABSORBENT
Product CodeFRL
Date Received2019-01-25
Returned To Mfg2018-12-21
Model Number2733
Catalog Number2733
Lot Number18G182862
Device AvailabilityR
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 2019-01-25

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