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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on june 28, 2023.
 
Event Description
Per the clinic, the patient underwent a skin revision surgery on (b)(6) 2015, due to unspecified medical reasons.Subsequently, the patient underwent another skin revision surgery on (b)(6) 2015, due to unspecified medical reasons.Additional information has been requested but has not been made available as of the date of this report.
 
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Brand Name
NI
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW  435 33
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW   435 33
Manufacturer Contact
nabila zahari
unit ug-1, vertical podium
no. 8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key17214286
MDR Text Key317982442
Report Number6000034-2023-02262
Device Sequence Number1
Product Code MAH
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 06/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2023
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;
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