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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on december 8, 2020.
 
Event Description
Per the clinic, the patient experienced an abscess resulting in an explant of the magnet on (b)(6) 2020.It is unknown if there are plans to re-implant the patient with another device.
 
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Brand Name
BIM400 IMPLANT MAGNET
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
MDR Report Key10963203
MDR Text Key220105277
Report Number6000034-2020-03405
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
Reporter Occupation Physician
Type of Report Initial
Report Date 11/18/2020
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
Device Operator Lay User/Patient
Device Model Number93550
Device Catalogue Number93550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/18/2020
Initial Date FDA Received12/07/2020
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age61 YR
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