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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUND PROCESSOR TAMPER-PROOF BATTERY DOOR; COCHLEAR BAHA CONNECT SYSTEM
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COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA 5 SOUND PROCESSOR TAMPER-PROOF BATTERY DOOR; COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 95331
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Per the clinic, it was reported the patient had thrown their sound processor which opened the tamper proof door on impact, as a result the patient had consumed the battery.The patient has been clinically managed, there was no allegation of serious injury or further consequences associated with the issue.
 
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Brand Name
BAHA 5 SOUND PROCESSOR TAMPER-PROOF BATTERY DOOR
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
Manufacturer Contact
kristel kohne
1 university avenue
macquarie university, nsw 2109,
AS   2109,
MDR Report Key7184537
MDR Text Key97049410
Report Number6000034-2018-00055
Device Sequence Number1
Product Code LXB
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
K142907
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Audiologist
Type of Report Initial
Report Date 12/19/2017
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 Number95331
Device Catalogue Number95331
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/19/2017
Initial Date FDA Received01/11/2018
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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