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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92132
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 11/20/2019
Event Type  Injury  
Event Description

Per the clinic, the patient underwent revision surgery on (b)(6) 2019, due to skin overgrowth at the implant site. The patient was placed under general anaesthesia and skin at the implant site was debrided. Following the procedure, the patient was placed on topical antibiotics and steroids.

 
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Brand NameBA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
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 Key9470979
MDR Text Key170852319
Report Number6000034-2019-02768
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 12/16/2019,11/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92132
Device Catalogue Number92132
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 FDA12/16/2019
Distributor Facility Aware Date11/20/2019
Event Location Hospital
Date Report TO Manufacturer12/16/2019
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: 12/15/2019 Patient Sequence Number: 1
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