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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA ATTRACT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Implant Pain (4561)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
This report is submitted on september 9, 2020.
 
Event Description
Per the clinic, the patient experienced pain at the implant site.The patient was placed under general anesthesia on (b)(6) 2020, in order to explant the device.
 
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Brand Name
ASKU
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
weiting zhen
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key10506093
MDR Text Key206092952
Report Number6000034-2020-02406
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/21/2020
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 NumberASKU
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/09/2020
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age10 YR
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