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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 6 MAX BATTERY DOOR - TAMPER RESISTANT; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 6 MAX BATTERY DOOR - TAMPER RESISTANT; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number P1668404
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Per the clinic, the patient ingested a battery from the sound processor.Subsequently, the patient was hospitalized (specific date and duration not reported) and the battery was passed out using laxatives.
 
Event Description
Correction: the correct brand name is baha 6 max battery door - tamper resistant; not baha 6 max, copper refurbished as previously reported.
 
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Brand Name
BAHA 6 MAX BATTERY DOOR - TAMPER RESISTANT
Type of Device
COCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
mölnlycke, 435 3 3
SW  435 33
MDR Report Key17253692
MDR Text Key318350533
Report Number6000034-2023-02087
Device Sequence Number1
Product Code MAH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/07/2023,06/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberP1668404
Device Catalogue NumberP1668404
Device Lot Number3010170193511
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2023
Distributor Facility Aware Date06/09/2023
Date Report to Manufacturer06/09/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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