FDA.reportPublic FDA data

MAUDE MDR 1759680

MDR report key
1759680
Report number
2086211-2010-00095
Event key
0
Event type
3
Date received
2010-07-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
HELEN LEWIS
Address
221 W. PHILA. ST., STE. 60 SUSQUEHANNA COMMERCE CTR W. YORK PA 17401 US
Phone
717-717-7178
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DISTAL END CUTTERGAC INTERNATIONALEJBODG-1016-L05-15N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-07-080

Event Narratives#

N

Patient 1

WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED IN THE PAST TWO YEARS INVOLVING A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS RETURNED FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT.

D

Patient 1

IT WAS REPORTED THAT THE TIP OF A DISTAL END CUTTER SEPARATED IN A PT'S MOUTH; NO INJURY RESULTED.