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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR LTD BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR LTD BIM400 IMPLANT MAGNET; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 93550
Device Problem Biocompatibility (2886)
Patient Problems Necrosis Of Flap Tissue (1972); Skin Irritation (2076)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on march 23, 2020.
 
Event Description
Per the clinic, the internal magnet was explanted on (b)(6) 2020, due to the patient developing recurrent irritation, necrosis and ulcers at the implant site.Prior to explant, the patient was treated with topical steroids; however, treatment was unsuccessful.
 
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Brand Name
BIM400 IMPLANT MAGNET
Type of Device
COCHLEAR BAHA ATTRACT SYSTEM
Manufacturer (Section D)
COCHLEAR LTD
1 university avenue
macquarie university, 2109
AS  2109
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9868182
MDR Text Key184636354
Report Number6000034-2020-00778
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeIT
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 02/25/2020
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 02/25/2020
Initial Date FDA Received03/23/2020
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 Age61 YR
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