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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 3 COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 3 COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 95773
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erosion (1750); Pressure Sores (2326)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the audiologist it was reported that the patient experienced significant skin breakdown at the magnet site subsequent to developing a pressure sore and the patient was treated with oral and topical antibiotics (date and duration not reported).

 
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Brand NameSP MAGNET 3
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
MDR Report Key7982778
MDR Text Key124310474
Report Number6000034-2018-02111
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 09/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/21/2018
Device MODEL Number95773
Device Catalogue Number95773
Device LOT Number120517
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
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: 10/19/2018 Patient Sequence Number: 1
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