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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 Problem Pain (1994)
Event Date 04/17/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
As per the clinic, the patient had a conversion from a baha attract configuration to a baha connect configuration on (b)(6) 2019.
 
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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
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
43533
SW   43533
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8598128
MDR Text Key144661112
Report Number6000034-2019-00754
Device Sequence Number1
Product Code LXB
UDI-Device Identifier09321502022385
UDI-Public09321502022385
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 Other Health Care Professional
Type of Report Initial
Report Date 04/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/29/2020
Device Model Number93550
Device Catalogue NumberCOH584365
Device Lot Number170823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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 Age23 YR
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