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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA ATTRACT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BI300 IMPLANT 4 MM; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number 92129
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Rash (2033); Skin Irritation (2076)
Event Date 02/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced headaches, skin irritation and a rash at the implant site.Subsequently the magnet and the implant were explanted on (b)(6) 2017.
 
Manufacturer Narrative
This report is submitted july 5, 2017.
 
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Brand Name
BI300 IMPLANT 4 MM
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 Contact
bianca hanlon
1 university avenue
macqaurie university, nsw 2109
AS   2109
94286555
MDR Report Key6383022
MDR Text Key69202266
Report Number6000034-2017-00491
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
K100360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 05/12/2017
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
Device Model Number92129
Device Catalogue Number92129
Device Lot NumberCOH824565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2017
Initial Date Manufacturer Received 02/28/2017
Initial Date FDA Received03/06/2017
Supplement Dates Manufacturer Received05/12/2017
Supplement Dates FDA Received07/04/2017
Was Device Evaluated by Manufacturer? Yes
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;
Patient Age52 YR
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