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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 Appropriate Term/Code Not Available (3191)
Patient Problems Abscess (1690); Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, the patient developed skin overgrowth and a subcutaneous abscess at the implant site.Subsequently, the patient underwent a procedure in order to excise the skin (date not reported).The implanted device remains.
 
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Brand Name
BA210 ABUTMENT 5.5MM FOR FLANGE FIXTURE
Type of Device
COCHLEAR 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
bianca hanlon
1 university avenue
macquarie university, nsw 2109,
AS   2109,
94286555
MDR Report Key6275128
MDR Text Key65664609
Report Number6000034-2017-00124
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K955713
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 01/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2017
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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