FDA.reportPublic FDA data

MAUDE MDR 9908112

MDR report key
9908112
Report number
6000034-2020-00872
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS BIANCA PRIES
Address
1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURECOCHLEAR BAHA CONNECT SYSTEMCOCHLEAR BONE ANCHORED SOLUTIONS ABLXBASKUASKUASKUR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. R

Event Narratives#

N

Patient 1

ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND DEVICE DETAILS; HOWEVER, HAVE NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT. SHOULD FURTHER INFORMATION BE PROVIDED, A SUPPLEMENTARY REPORT SHALL BE SUBMITTED. THIS REPORT IS SUBMITTED ON APRIL 1, 2020.

D

Patient 1

PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020, IN ORDER TO EXCISE EXCESS SKIN AT THE IMPLANT SITE. THE IMPLANTED FIXTURE REMAINS INSITU.