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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  Injury  
Event Description
Per the clinic, the implant magnet was explanted under general anesthesia on (b)(6) 2023.
 
Manufacturer Narrative
This report is submitted on july 31, 2023.
 
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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
mölnlycke, 435 3 3
SW  435 33
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW   435 33
Manufacturer Contact
hakim muhaimin jamil
unit ug-1, vertical podium
no. 8 jalan kerinchi
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key17422219
MDR Text Key320015405
Report Number6000034-2023-02436
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 07/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2023
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
Date Manufacturer Received07/12/2023
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 Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age13 YR
Patient SexMale
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