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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 6; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 6; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 95776
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Implanted device remains.
 
Event Description
Per the clinic, the patient experienced redness and swelling at abutment site, however the issue could not be resolved; subsequently the patient was administered antibiotics (type and date not reported).
 
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Brand Name
SP MAGNET 6
Type of Device
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer (Section G)
COCHLEAR AMERICAS
13059 east parkview avenue
centennial CO 80111
Manufacturer Contact
kristel kohne
1 university avenue
macqaurie university, nsw 2109
AS   2109
2 9428 655
MDR Report Key6128202
MDR Text Key60903960
Report Number6000034-2016-02352
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial
Report Date 11/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number95776
Device Catalogue Number95776
Device Lot Number107596
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date11/15/2016
Date Manufacturer Received11/15/2016
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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