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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92130
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on february 19, 2021.
 
Event Description
Per the clinic, the patient experienced recurrent infections at the abutment site.At the time of the abutment removal, there was no infection but oral and iv antibiotics were administered prophylactically.A skin revision was performed.The implant remains in-situ.The patient was converted to a baha attract system on (b)(6) 2021.
 
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Brand Name
BA300 ABUTMENT 6MM
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW  435 22
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key11346705
MDR Text Key232506930
Report Number6000034-2021-00470
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/29/2021
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 Number92130
Device Catalogue Number92130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2021
Initial Date FDA Received02/18/2021
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;
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