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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 POWER SOUNDPROCESSOR, BROWN; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 POWER SOUNDPROCESSOR, BROWN; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95473
Device Problem Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the disposable battery inside the sound processor malfunctioned and exploded causing the patient singed hair (specific date not reported).
 
Manufacturer Narrative
This report is submitted on may 08, 2023.
 
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Brand Name
BAHA 5 POWER SOUNDPROCESSOR, BROWN
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
kalai tamilselvan
unit ug-1, vertical podium
no. 8 jalan kerinchi,
kuala lumpur, wilayah persekutuan 59200
MY   59200
MDR Report Key16884557
MDR Text Key314708592
Report Number6000034-2023-01410
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
PMA/PMN Number
K161123
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 04/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number95473
Device Catalogue Number95473
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/17/2023
Initial Date FDA Received05/08/2023
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) Other;
Patient SexMale
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