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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB ASKU; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number ASKU
Device Problem Biocompatibility (2886)
Patient Problems Unspecified Infection (1930); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on decmeber 24, 2019.
 
Event Description
Per the clinic, it was reported that the patient is experiencing skin irritation and infections at the abutment site.It is unknown what treatment has been administered, as of the date of this report.
 
Manufacturer Narrative
Per the clinic, it was reported that the patient was treated had received treatment with topical and oral antibiotics; however, this did not resolve the irritation and infections at the implant site.The patient is continuing clinical management by their healthcare provider.This report is submitted march 24, 2020.
 
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Brand Name
ASKU
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
MDR Report Key9513470
MDR Text Key172617288
Report Number6000034-2019-02909
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/27/2020
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 12/04/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received02/27/2020
Supplement Dates FDA Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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