FDA.reportPublic FDA data

MAUDE MDR 8633887

MDR report key
8633887
Report number
1037955-2019-00020
Event key
0
Event type
3
Date received
2019-05-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. CHRIS FELABOM
Address
1155 ROBERTS BLVD. SUITE 100 KENNESAW GA 30144 US
Phone
770-770-7705
Report source
D
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DORNIER DELTA IIILITHOTRIPTERDORNIER MEDTECH SYSTEMS GMBHLNSDORNIER DELTA IIIK1039062Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-2201. O

Event Narratives#

N

Patient 1

A SERVICE REPORT COMPLETED AND DATED 05/16/2019 BY A DMTA FIELD SERVICE ENGINEER INDICATED THAT THE DEVICE WAS IN COMPLIANCE WITH DORNIER SPECIFICATIONS. A HEMATOMA IS LISTED AS A POTENTIAL ADVERSE EFFECT AND COMPLICATION IN THE DELTA III OPERATING MANUAL. THE DETAILS CONCERNING INDIVIDUAL PATIENT OUTCOMES ARE UNKNOWN. NO FAULT WITH THE DEVICE AS MANUFACTURED. DEVICE WAS FOUND TO BE FUNCTIONING WITHIN DORNIER SPECIFICATIONS. (B)(4).

D

Patient 1

PATIENT HEMATOMA REPORTED.