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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Type  Injury  
Event Description

Per the clinic, the patient developed and infection and purulent discharge at the implant site. Subsequently, the patient was treated with oral antibiotics (date and duration not reported). The implanted device remains insitu. The patient continues to be clinically managed by their healthcare provider.

 
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Brand NameNI
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
MDR Report Key8963315
MDR Text Key156576533
Report Number6000034-2019-01735
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 09/05/2019,08/23/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberASKU
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2019
Event Location Other
Date Report TO Manufacturer09/05/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/04/2019 Patient Sequence Number: 1
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