3202674-005 REDIPAK 1P 10B 50C PM20022

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 2019-10-23 for 3202674-005 REDIPAK 1P 10B 50C PM20022 manufactured by Covidien.

MAUDE Entry Details

Report Number1219103-2019-00241
MDR Report Key9224774
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-23
Date of Report2019-10-23
Date of Event2019-10-09
Date Mfgr Received2019-10-09
Date Added to Maude2019-10-23
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 Street2 LUDLOW PARKWAY
Manufacturer CityCHICOPEE MA 01022
Manufacturer CountryUS
Manufacturer Postal Code01022
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3202674-005 REDIPAK 1P 10B 50C
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2019-10-23
Model NumberPM20022
Catalog NumberPM20022
Lot Number702026
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-23

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