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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92133
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative

This report is submitted on ocytober 20, 2020.

 
Event Description

Per the clinic, the patient experienced suppuration (infection) and skin overgrowth of the abutment. Treatment to the infection is unknown).

 
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Brand NameBA210 ABUTMENT 8.5MM 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
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key10702282
MDR Text Key212063703
Report Number6000034-2020-02973
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
PMA/PMN NumberK955713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number92133
Device Catalogue Number92133
Device LOT NumberCOH185620
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/29/2020
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: 10/19/2020 Patient Sequence Number: 1
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