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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 3MM; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Necrosis Of Flap Tissue (1972); Post Operative Wound Infection (2446); Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on november 29, 2019.
 
Event Description
Per the surgeon, the patient experienced a wound breakdown, skin necrosis and an infection.The infection was treated with antibiotics (type of administration is unknown).The implant remains in-situ.
 
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Brand Name
BI300 IMPLANT 3MM
Type of Device
COCHLEAR BAHA ATTRACT 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
43533
SW   43533
Manufacturer Contact
roberta loveday
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key9390521
MDR Text Key168443981
Report Number6000034-2019-02817
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K131240
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2019
Initial Date FDA Received11/28/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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