DERMACEA X-RAY 4X8 12 PLY STRL 441602

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 2020-03-09 for DERMACEA X-RAY 4X8 12 PLY STRL 441602 manufactured by Covidien.

Event Text Entries

[182711342] 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


[182711343] The customer reported that the pack contained 11 sponges instead of 10, as labeled. The miscount was discovered during the initial count when setting up. There was no injury associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1282497-2020-08960
MDR Report Key9808318
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-25
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-09
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 4X8 12 PLY STRL
Generic NameGAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Product CodeGDY
Date Received2020-03-09
Model Number441602
Catalog Number441602
Lot Number190511-120-SH
Device Availability*
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 2020-03-09

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