ASKU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for ASKU manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[184455839] This report is submitted on march 13, 2020.
Patient Sequence No: 1, Text Type: N, H10


[184455840] Per the clinic, the patient experienced skin overgrowth. There was a skin revision on (b)(6) 2020 under a general anaesthetic and the patient was treated with antibiotics (type unknown).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00689
MDR Report Key9827658
Date Received2020-03-12
Date of Report2020-02-18
Date of Event2020-01-09
Report Date2020-03-13
Date Reported to FDA2020-03-13
Date Reported to Mfgr2020-02-18
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 CodeMAH
Date Received2020-03-12
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrN
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 2020-03-12

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