FDA.reportPublic FDA data

MAUDE MDR 5955798

MDR report key
5955798
Report number
MW5064796
Event key
0
Event type
3
Date of event
2016-06-20
Date received
2016-09-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BAHA 4HEARING AIDCOCHLEAR AMERICASESD* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-09-1401. R

Event Narratives#

D

Patient 1

I WEAR A BAHA 4 (BONE ANCHORED HEARING AID) DEVICE FROM COCHLEAR AMERICAS. AS I WALKED MY DOG THROUGH THE PARK, SOME YOUNG ADULTS HIT ME ON THE HEAD, DIRECTLY ON THE DEVICE, WITH A BASEBALL. THE DEVICE FLEW OFF AND REQUIRED REPAIR. IN ADDITION, THE TITANIUM ABUTMENT/IMPLANT BROKE AND THE SURROUNDING SKIN BECAME INFECTED. I NEEDED DEBRIDEMENT SURGERY. I ALSO NEED A NEW ABUTMENT BUT COCHLEAR DID NOT COOPERATE WITH THIS. MY DOCTOR ATTEMPTED TO REPAIR THE DEVICE BUT THE DAMAGE WAS SEVERE. SURGERY ON (B)(6) 2016.