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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 Appropriate Term/Code Not Available (3191)
Patient Problem Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Additional information has been requested regarding the patient and device details; however, have not been made available as of the date of this report.Should further information be provided, a supplementary report shall be submitted.This report is submitted on june 29, 2020.
 
Event Description
Per the clinic, it was reported that the patient developed swelling at the implant site and subsequently received injections (type not reported) to treat the swelling.
 
Manufacturer Narrative
Per the clinic, it was confirmed that the patient had developed an infection at the implant site and was subsequently treated with topical antibiotics.This report is submitted july 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 Key10204560
MDR Text Key197095622
Report Number6000034-2020-01588
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 07/01/2020
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 06/05/2020
Initial Date FDA Received06/28/2020
Supplement Dates Manufacturer Received07/01/2020
Supplement Dates FDA Received07/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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