ORTHO SUMMIT PROCESSOR 7003015 936480

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-03 for ORTHO SUMMIT PROCESSOR 7003015 936480 manufactured by Hamilton Bonaduz Ag.

Event Text Entries

[372738] User error. The customer used the wrong correction factor when performing dispenser verifications on the ortho summit processor. No death or serious injury was assoicated with the incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2250051-2004-02604
MDR Report Key584787
Date Received2004-06-03
Date of Report2004-06-03
Date of Event2004-05-04
Date Added to Maude2005-03-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameORTHO SUMMIT PROCESSOR
Generic NameELISA MICROWELL PLATE PROCESSOR
Product CodeJTL
Date Received2004-06-03
Model Number7003015
Catalog Number936480
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key574615
ManufacturerHAMILTON BONADUZ AG
Manufacturer Address* BONADUZ SZ CH 7402
Baseline Brand NameORTHO SUMMIT PROCESSOR
Baseline Generic NameSAMPLE PROCESSOR
Baseline Model No7003015
Baseline Catalog No936480
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2004-06-03

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