MEDI-TRACE CADENCE 22550R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for MEDI-TRACE CADENCE 22550R manufactured by Covidien Chicopee Mfg Dc.

Event Text Entries

[115105321] The incident sample has been requested but to date has not been received for evaluation by the manufacturer. 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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[115105322] The customer reported the gel on the defibrillator pad was coming off.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219103-2018-00012
MDR Report Key7715506
Date Received2018-07-24
Date of Report2018-10-04
Date Mfgr Received2018-08-08
Device Manufacturer Date2017-03-01
Date Added to Maude2018-07-24
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 CHICOPEE MFG DC
Manufacturer Street2 LUDLOW PARK DR
Manufacturer CityCHICOPEE MA 010221318
Manufacturer CountryUS
Manufacturer Postal Code010221318
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameMEDI-TRACE CADENCE
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeMLN
Date Received2018-07-24
Model Number22550R
Catalog Number22550R
Lot Number705913X
Device Expiration Date2019-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerCOVIDIEN CHICOPEE MFG DC
Manufacturer Address2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318

Device Sequence Number: 1

Brand NameMEDI-TRACE CADENCE
Generic NamePACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
Product CodeDRO
Date Received2018-07-24
Model Number22550R
Catalog Number22550R
Lot Number705913X
Device Expiration Date2019-03-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN CHICOPEE MFG DC
Manufacturer Address2 LUDLOW PARK DR CHICOPEE MA 010221318 US 010221318


Patients

Patient NumberTreatmentOutcomeDate
10 2018-07-24

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