BIA400 IMPLANT 4MM W ABUTMENT 12MM 93332

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 2020-03-18 for BIA400 IMPLANT 4MM W ABUTMENT 12MM 93332 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[184054776] This report is submitted on 19 march 2020.
Patient Sequence No: 1, Text Type: N, H10


[184054777] Per the clinic, the patient experienced pain with device use and subsequently was treated with topical and iv antibiotics and general anaesthesia. Clinical management is ongoing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000034-2020-00772
MDR Report Key9851152
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-18
Date of Report2020-02-24
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-18
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
Manufacturer ContactMS. KRISTEL KOHNE
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 NameBIA400 IMPLANT 4MM W ABUTMENT 12MM
Generic NameCOCHLEAR BAHA CONNECT SYSTEM
Product CodeMAH
Date Received2020-03-18
Model Number93332
Catalog Number93332
Lot NumberCOH1277635
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-18

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