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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, BLONDE COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUNDPROCESSOR, BLONDE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

Per the clinic, the patient experienced skin swollen over the abutment. Treatment with steroid injections were successful.

 
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Brand NameBAHA 5 SOUNDPROCESSOR, BLONDE
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 Key8933483
MDR Text Key155638058
Report Number6000034-2019-01589
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 08/27/2019,08/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number95201
Device Catalogue Number95201
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Distributor Facility Aware Date10/15/2019
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: 08/26/2019 Patient Sequence Number: 1
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