ASKU

MAUDE Adverse Event Report

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

Event Text Entries

[186732634] Per the clinic, it was reported that the patient suffered a blow to the implant site, resulting in a loss of osseointegration and fixture loss. The patient will be reimplanted at a later date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00894
MDR Report Key9907969
Date Received2020-03-31
Date of Report2020-03-06
Date of Event2020-03-06
Date Facility Aware2020-03-06
Report Date2020-04-01
Date Reported to FDA2020-04-01
Date Reported to Mfgr2020-04-01
Date Added to Maude2020-03-31
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
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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