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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAP MAGNET BEIGE 3DOT COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAP MAGNET BEIGE 3DOT COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on december 29, 2017. (b)(4).

 
Event Description

Per the clinic, the patient experienced skin irritation and pain at magnet site and subsequently was treated with oral and iv antibiotics (date and duration not reported). The implanted device remains.

 
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Brand NameBAP MAGNET BEIGE 3DOT
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
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7153359
MDR Text Key96002316
Report Number6000034-2017-02358
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
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: 12/28/2017 Patient Sequence Number: 1
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