FDA.reportPublic FDA data

MAUDE MDR 7598026

MDR report key
7598026
Report number
1832462-2018-00003
Event key
0
Event type
3
Date of event
2018-05-02
Date received
2018-06-13
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
ADRIENNE DEMLAND
Address
4321 GOSHEN RD. FORT WAYNE IN 46818 US
Phone
800-800-8006
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PANORAMIC X-RAY MODEL PC-1000PC-1000YOUNG INNOVATIONSEHD800724-1R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1301. O

Event Narratives#

N

Patient 1

THE DENTIST EMAILED AND STATED THAT THE SCREW MOTOR ASSEMBLY FAILED. THE OVERHEAD CHASSIS LIGHTLY MADE CONTACT WITH A GIRL. THE DENTIST APPLIED ANTIBIOTIC AND A BAND-AID. THE MOTHER TOOK THE GIRL TO THE PHYSICIAN TO MAKE SURE SHE WAS ALRIGHT. THE PHYSICIAN REAPPLIED ANTIBIOTIC AND A BAND-AID. THE GIRL WAS NOT HOSPITALIZED. THE DENTIST PURCHASED A SCREW MOTOR AND HAD IT SHIPPED TO HIS OFFICE. HE IS HAVING HIS OWN TECHNICIAN REPLACE THE MOTOR SINCE THERE ARE NO PANORAMIC CERTIFIED TECHNICIANS IN (B)(4).

D

Patient 1

DR. (B)(6) NOTIFIED US BE EMAIL ON (B)(6) 2018 THAT THREE WEEKS PRIOR (1ST WEEK OF (B)(6)APPROXIMATELY), A PATIENT WAS ENTERING THE UNIT AND THE SCREW MOTOR ASSEMBLY FAILED. THE OVERHEAD CHASSIS MADE CONTACT WITH THE PATIENT. ON (B)(6) 2018, THE DOCTOR GAVE US THE SERIAL NUMBER AND OTHER REQUIRED INFORMATION FOR THIS INCIDENT SO WE COULD INVESTIGATE AND CREATE A CASE. THE SCREW MOTOR IS STUCK NOW AND WILL NOT GO UP. THE PATIENT WAS SCRAPED ON THE CHEEK AND SHOULDER. THE PATIENT WAS TREATED WITH ANTIBIOTIC AND A BAND-AID ON THE CHEEK.