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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number UNKNOWN
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative

Device details unavailable as of the date of this report, this report is submitted on may 23, 2017. (b)(4).

 
Event Description

Per the clinic, it was found that a device was implanted beyond the sterilisation expiry date.

 
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Brand NameUNKNOWN
Type of DeviceCOCHLEAR 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,
94286555
MDR Report Key6583752
MDR Text Key75715756
Report Number6000034-2017-00952
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberUNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2017
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

Patient TREATMENT DATA
Date Received: 05/22/2017 Patient Sequence Number: 1
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