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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 92129
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Staphylococcus Aureus (2058)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Implanted device remains.

 
Event Description

Per the clinic, the patient experienced a discharge at the incision site and cultures returned positive for staph infection. Subsequently on (b)(6) 2017, the patient was administered oral antibiotics. The issue has since resolved.

 
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Brand NameBI300 IMPLANT 4 MM
Type of DeviceCOCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer Contact
sujeewa wijesinghe
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6586870
MDR Text Key75815431
Report Number6000034-2017-01031
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial
Report Date 05/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92129
Device Catalogue Number92129
Device LOT NumberCOH1089595
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/24/2017 Patient Sequence Number: 1
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