ALLEGIENCE 1061 SEY26BSWHA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-19 for ALLEGIENCE 1061 SEY26BSWHA manufactured by Allegience.

Event Text Entries

[243207] Drape used during surgery. When drape was removed by physician part of pt's eyebrow was removed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number377849
MDR Report Key377849
Date Received2002-02-19
Date of Report2002-02-19
Date of Event2002-02-06
Date Facility Aware2002-02-06
Report Date2002-02-19
Date Reported to FDA2002-02-19
Date Reported to Mfgr2002-02-19
Date Added to Maude2002-02-25
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALLEGIENCE
Generic NameEYE DRAPE
Product CodeHMT
Date Received2002-02-19
Returned To Mfg2002-02-08
Model Number1061
Catalog NumberSEY26BSWHA
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key366896
ManufacturerALLEGIENCE
Manufacturer Address1450 WAUKEGAN RD MCGAW PARK IL 60085 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-02-19

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