FDA.reportPublic FDA data

MAUDE MDR 6519384

MDR report key
6519384
Report number
9611253-2017-00021
Event key
0
Event type
3
Date of event
2017-03-21
Date received
2017-04-25
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-E2SH266Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-2501. O

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

ON APRIL 6, 2017, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A HANDPIECE OVERHEATING. DETAILS ARE AS FOLLOWS. - ON (B)(6) 2017, (B)(4) WAS MADE AWARE OF THE EVENT BY AN NSK SALES REPRESENTATIVE. - THE EVENT OCCURRED ON (B)(6) 2017. - A DENTIST WAS PERFORMING A SURGICAL EXTRACTION OF TOOTH #3 ON A PATIENT USING AN NSK HANDPIECE, SGS-E2S (SERIAL NO. (B)(4)). - THE PATIENT WAS UNDER LOCAL ANESTHESIA. - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED AND THE PATIENT COMPLAINED ABOUT A BURNING SENSATION ON THE CORNER OF THE OUTER LIP. - THE DENTIST FOUND A SUPERFICIAL EPIDERMAL BURN, 6MM IN DIAMETER ON THE SKIN OF THE LOWER LIP INFERIOR LATERAL TO COMMISSURE. - THE DENTIST APPLIED HAWAIIAN MOON ALOE VERA TO THE PATIENT'S SKIN. - NO FOLLOW-UP WAS SCHEDULED WITH THE PATIENT. - THE PATIENT HAS RECOVERED FROM THE BURN INJURY. - ACCORDING TO THE DENTIST, THERE WERE NO ABNORMALITIES OR MALFUNCTIONS OBSERVED WITH THE HANDPIECE PRIOR TO USE.