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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BIA300 IMPLANT 3MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 92126
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812)
Event Date 05/29/2015
Event Type  Injury  
Manufacturer Narrative

This report is submitted on may 17, 2018, (b)(4).

 
Event Description

Per the clinic, the patient developed cellulitis at the implant site and was treated with antibiotics (type not reported) on (b)(6) 2015. On (b)(6) 2015, the patient experienced skin overgrowth at the implant site. Subsequently, a biopsy punch was performed in order to expose the implant. On (b)(6) 2016, the patient experienced an infection at the implant site, and was treated with oral antibiotics; however, the issue reoccurred, and the patient presented once more to clinic on (b)(6) 2016, with infection. The patient was treated with another course of oral antibiotics.

 
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Brand NameBIA300 IMPLANT 3MM W ABUTMENT 6MM
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 (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke 43533
SW 43533
Manufacturer Contact
bianca pries
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key7521086
MDR Text Key108482122
Report Number6000034-2018-01138
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation AUDIOLOGIST
Type of Report Initial
Report Date 04/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2016
Device MODEL Number92126
Device Catalogue Number92126
Device LOT Number91160
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/19/2018
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: 05/16/2018 Patient Sequence Number: 1
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