ASKU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for ASKU manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[186351758] This report is submitted on april 1, 2020.
Patient Sequence No: 1, Text Type: N, H10


[186351759] Per the clinic, it was reported that the patient has experienced recurrent pain and infections at the implant site. Treatment with multiple courses of antibiotics were administered; however, treatment was unsuccessful. Subsequently, the patient underwent revision surgery was performed to excise skin at the implant site and explant the device (date not reported).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00905
MDR Report Key9908836
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS BIANCA PRIES
Manufacturer Street1 UNIVERSITY AVENUE
Manufacturer CityMACQUARIE UNIVERSITY, NSW 2109
Manufacturer CountryAS
Manufacturer Postal2109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASKU
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeLXB
Date Received2020-03-31
Model NumberASKU
Catalog NumberASKU
Lot NumberASKU
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOCHLEAR BONE ANCHORED SOLUTIONS AB
Manufacturer AddressKONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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