*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-01-17 for * manufactured by *.

Event Text Entries

[17234377] Device will not be returned due to end user cannot determine which cord was involved in the incident.
Patient Sequence No: 1, Text Type: N, H10


[17248624] It was reported that at the end of the procedure, the physician handed the scope to the scrub tech and asked for the light to be turned off. The light cord was put down on the drape. Moments later a black hole in the drape was noticed. The drape was removed and the pt was found to have a burn on the lower lip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1418479-2007-00001
MDR Report Key813648
Report Source06
Date Received2007-01-17
Date of Report2007-01-17
Date Facility Aware2006-12-11
Report Date2007-01-17
Date Mfgr Received2006-12-20
Date Added to Maude2007-02-09
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 ContactELEANOR HALL
Manufacturer Street353 CORPORATE WOODS PARKWAY
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer Phone8479558016
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name*
Generic Name*
Product CodeFFZ
Date Received2007-01-17
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device Availability*
Device AgeUNKNOWN
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key801137
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2007-01-17

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