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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 6 SOUND PROCESSOR, SILVER; COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 6 SOUND PROCESSOR, SILVER; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number P1668391
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Necrosis (1971); Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
This report is submitted on april 3, 2024.
 
Event Description
Per the clinic, the patient experienced a skin necrosis and breakdown with external device use.The device has been replaced with an extended coupler.
 
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Brand Name
BAHA 6 SOUND PROCESSOR, SILVER
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
mastura ruhanet
unit ug-1, vertical podium
no. 8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key19032446
MDR Text Key339244274
Report Number6000034-2024-01187
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K202048
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 03/08/2024
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 NumberP1668391
Device Catalogue NumberP1668391
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/08/2024
Initial Date FDA Received04/03/2024
Was Device Evaluated by Manufacturer? No
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 SexFemale
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