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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Host-Tissue Reaction (1297)
Event Date 10/25/2019
Event Type  Injury  
Event Description
Per the clinic, the patient underwent revision on (b)(6) 2019, in order to excise skin at the implant site.Revision surgery was successful and the implanted device remains insitu.
 
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Brand Name
NI
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
MDR Report Key9435198
MDR Text Key169795953
Report Number6000034-2019-02670
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/09/2019,11/15/2019
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 NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2019
Distributor Facility Aware Date11/15/2019
Event Location Hospital
Date Report to Manufacturer12/09/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age11 YR
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