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 user facility report with the FDA on 2018-12-18 for 2733 SPG GAUZE 4X4-16PLY manufactured by Covidien.

Event Text Entries

[130788225] The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10


[130788226] The customer states the gauze is coming apart; excessive linting.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018120-2018-00322
MDR Report Key8176354
Report SourceUSER FACILITY
Date Received2018-12-18
Date of Report2019-02-06
Date of Event2018-11-16
Date Mfgr Received2018-11-21
Date Added to Maude2018-12-18
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 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 Received2018-12-18
Model Number2733
Catalog Number2733
Lot Number18D149762
OperatorHEALTH PROFESSIONAL
Device Availability*
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 2018-12-18

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