FDA.reportPublic FDA data

MAUDE MDR 6563159

MDR report key
6563159
Report number
9611253-2017-00026
Event key
0
Event type
3
Date of event
2017-04-07
Date received
2017-05-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR KENNETH BLOCK
Address
800 E CAMPBELL RD. SUITE 202 RICHARDSON TX 75081 US
Phone
972-972-9724
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NSKHANDPIECE, ROTARY BONE CUTTINGNAKANISHI INC.KMWSGS-E2SH266001Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-05-1201. O

Event Narratives#

N

Patient 1

(B)(4). THE INFORMATION RECEIVED FROM (B)(4) IS AS FOLLOWS. - ON APRIL 17, 2017, AND APRIL 20, 2017, (B)(4) CONTACTED THE DENTAL OFFICE BY PHONE AND EMAIL TO REQUEST PATIENT INFORMATION, BUT THE DENTAL OFFICE DID NOT DISCLOSE THE PATIENT INFORMATION. - NO SERVICE HAS BEEN CONDUCTED AT (B)(4) ON THE SUBJECT DEVICE ((B)(4)).

D

Patient 1

ON APRIL 24, 2017, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ((B)(4)) DESCRIBING A PATIENT INJURY. DETAILS ARE AS FOLLOWS. - ON APRIL 13, 2017, (B)(4) WAS MADE AWARE OF AN UNCONFIRMED PATIENT INJURY FROM INFORMATION PROVIDED FROM THE INCOMING SERVICE REPAIR PAPERWORK. - THE EVENT OCCURRED ON (B)(6) 2017. - (B)(4) IMMEDIATELY CONTACTED THE DENTAL OFFICE AND SPOKE WITH THE DENTIST'S ASSISTANT. - THE DENTIST'S ASSISTANT STATED THAT THE NECK OF THE HANDPIECE BECAME EXTREMELY HOT AND BURNED A PATIENT'S LIP. - NO OTHER INFORMATION REGARDING THE PATIENT WAS AVAILABLE AT THIS TIME. - (B)(4) CONTACTED THE DENTAL OFFICE TO OBTAIN MORE INFORMATION , AND THE NSK PATIENT INFORMATION FORM WAS IMMEDIATELY FORWARDED TO THE DENTAL OFFICE TO BE COMPLETED.