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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA DIVINO BLONDE COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA DIVINO BLONDE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 90500
Device Problem Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative

Patient details unavailable at the time of this report, this report is submitted on (b)(6) 2017.

 
Event Description

It was reported that the rechargeable battery is leaking fluid. The patient has been advised to discontinue use of the battery and return it to the manufacturer for evaluation. There was no allegation of serious injury associated with the issue. Replacement equipment was sent to the patient. The rechargeable battery has not been returned as of the date of this report.

 
Manufacturer Narrative

Correction: the initial mdr submitted on may 24, 2017 was filed inadvertently. The rechargeable battery was a disposable battery that was not a cochlear manufactured product.

 
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Brand NameBAHA DIVINO BLONDE
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2,
SW 435 22,
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6586701
MDR Text Key75814764
Report Number6000034-2017-00993
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK042017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number90500
Device Catalogue Number90500
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/23/2017 Patient Sequence Number: 1
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