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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 93336
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on july 30, 2020.

 
Event Description

Per the clinic, it was reported that the patient experienced chronic infections at the implant site. Treatment with oral and topical antibiotics were unsuccessful. Subsequently, the patient's abutment was removed under general anesthesia in (b)(6) 2019 (specific date not reported). The patient received iv antibiotics and steroids during the procedure. The infection has since healed.

 
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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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
po box 82
molnlycke, 435 2 2
SW 435 22
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10342084
MDR Text Key200963875
Report Number6000034-2020-01929
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/07/2020
Device MODEL Number93336
Device Catalogue Number93336
Device LOT Number174172
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
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 TREATMENT DATA
Date Received: 07/29/2020 Patient Sequence Number: 1
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