DERMACEA USP7 4X4 16PLY NS 441210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-05 for DERMACEA USP7 4X4 16PLY NS 441210 manufactured by Covidien.

Event Text Entries

[123382441] 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.
Patient Sequence No: 1, Text Type: N, H10


[123382442] The customer reports the product was found to be flaking.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2018-08098
MDR Report Key7939941
Report SourceDISTRIBUTOR
Date Received2018-10-05
Date of Report2018-10-05
Date of Event2018-09-28
Date Mfgr Received2018-09-28
Date Added to Maude2018-10-05
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 ContactEDWARD ALMEIDA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5084524151
Manufacturer G1COVIDIEN
Manufacturer Street15 HAMPSHIRE ST
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDERMACEA USP7 4X4 16PLY NS
Generic NameGAUZE/SPONGE,NONRESORBABLE FOR EXTERNAL USE
Product CodeNAB
Date Received2018-10-05
Model Number441210
Catalog Number441210
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address15 HAMPSHIRE ST MANSFIELD MA


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-05

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