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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
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Ulcer (2274)
Date of Event 09/10/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
Per the clinic, the patient experienced an ulcer at the magnet site.The patient is being clinically managed by their health care provider.
 
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Brand Name
SP MAGNET 3
Common Device Name
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
MDR Report Key6885646
Report Number6000034-2017-01754
Device Sequence Number16333810
Product Code LXB
UDI-Device Identifier09321502028691
UDI-Public(01)09321502028691(10)113749(17)180228
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
NI
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 09/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Lay User/Patient
Device Expiration Date02/18/2018
Device Model Number95773
Device Catalogue Number95773
Device Lot Number113749
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/10/2017
Initial Report FDA Received Date09/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age26 YR
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