F/O CABLE ACMI/ACMI 7.5' 88-9727 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-08 for F/O CABLE ACMI/ACMI 7.5' 88-9727 * manufactured by Cardinal Health (snowden Pencer).

Event Text Entries

[356533] During a breast aug. Patient was burned by light cord connector-also cord itself was much hotter than ever before. At the end of case a raised fluid blister was noted. Tegaderm placed by doctor. 8/2004 antibiotic applied by doctor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038548-2004-00023
MDR Report Key542563
Date Received2004-09-08
Date of Report2004-09-08
Date of Event2004-08-06
Date Facility Aware2004-08-06
Report Date2004-09-08
Date Mfgr Received2004-08-06
Date Added to Maude2004-09-10
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 ContactMICHELE DONATICH
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal60085
Manufacturer Phone8477853309
Manufacturer G1CARDINAL HEALTH (SNOWDEN PENCER)
Manufacturer Street1500 WAUKEGAN ROAD
Manufacturer CityMCGAW PARK IL 60085
Manufacturer CountryUS
Manufacturer Postal Code60085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameF/O CABLE ACMI/ACMI 7.5'
Generic Name*
Product CodeFSX
Date Received2004-09-08
Returned To Mfg2004-08-18
Model Number88-9727
Catalog Number*
Lot Number779401
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedU
Device Sequence No1
Device Event Key531931
ManufacturerCARDINAL HEALTH (SNOWDEN PENCER)
Manufacturer Address* MCGAW PARK IL * US
Baseline Brand NameF/O CABLE ACMI.ACMI 7.5
Baseline Generic Name*
Baseline Model No88-9727
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-09-08

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