FDA.reportPublic FDA data

MAUDE MDR 8637355

MDR report key
8637355
Report number
1017768-2019-00644
Event key
0
Event type
3
Date of event
2019-05-16
Date received
2019-05-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1401 DENTAL NDL 30SHNEEDLE, DENTALCOVIDIENDZM88814010728881401072903518R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-230

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

D

Patient 1

THE CUSTOMER REPORTED THE NEEDLES COME OFF WHEN TAKING THE CAP OFF. THERE WAS NO HARM TO THE PATIENT.