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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92133
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient experienced infection at implant site and subsequently was treated with antibiotics (type and duration not reported); subsequently the patient was placed under general anesthetic and underwent skin revision surgery to remove abutment.
 
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Brand Name
BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
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
kristel kohne
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8694253
MDR Text Key147852798
Report Number6000034-2019-00938
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 05/23/2019
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 Number92133
Device Catalogue Number92133
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Initial Date Manufacturer Received 05/23/2019
Initial Date FDA Received06/12/2019
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;
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