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U.S. Department of Health and Human Services

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

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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cellulitis (1768); Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description

Per the clinic, the patient experienced an infection and cellulitis which was treated with oral and topical antibiotics.

 
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Brand NameASKU
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
MDR Report Key11600573
MDR Text Key243319622
Report Number6000034-2021-00855
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
Type of Report Initial,Followup
Report Date 05/03/2021,04/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2021
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 FDA05/03/2021
Distributor Facility Aware Date04/09/2021
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/31/2021 Patient Sequence Number: 1
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