DERMACEA X-RAY SPG 4X4 16 PLY 441601

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 2020-02-11 for DERMACEA X-RAY SPG 4X4 16 PLY 441601 manufactured by Covidien.

Event Text Entries

[178606822] The incident sample has been requested but to date has not been received at the manufacturing site 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


[178606823] The customer reported that there are 2 extra raytec. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2020-08915
MDR Report Key9693426
Report SourceDISTRIBUTOR
Date Received2020-02-11
Date of Report2020-02-11
Date Mfgr Received2020-01-20
Date Added to Maude2020-02-11
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDERMACEA X-RAY SPG 4X4 16 PLY
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2020-02-11
Model Number441601
Catalog Number441601
Lot Number190118-115-SH
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-11

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