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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  
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
MDR Report Key10342085
MDR Text Key201499313
Report Number6000034-2020-01930
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
Report Date 07/30/2020,07/08/2020
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? Yes
Date Report Sent to FDA07/30/2020
Distributor Facility Aware Date07/08/2020
Event Location Hospital
Date Report TO Manufacturer07/30/2020
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: 07/29/2020 Patient Sequence Number: 1
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