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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR WIRELESS PHONE CLIP COCHLEAR BAHA CONNECT SYSTEM

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COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR WIRELESS PHONE CLIP COCHLEAR BAHA CONNECT SYSTEM Back to Search Results
Model Number 94771
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that recipient's baha phone clip allegedly melted while charging. Cochlear has requested the phone clip to be retrieved for an evaluation.

 
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Brand NameCOCHLEAR WIRELESS PHONE CLIP
Type of DeviceCOCHLEAR BAHA CONNECT SYSTEM
Manufacturer (Section D)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
mölnlycke, 435 2 2
SW 435 22
Manufacturer (Section G)
COCHLEAR BONE ANCHORED SOLUTIONS AB
konstruktionsvägen 14
po box 82
43533
SW 43533
Manufacturer Contact
yi feng
1 university avenue
macquarie university, nsw 2109
AS   2109
MDR Report Key8824867
MDR Text Key152158145
Report Number6000034-2019-01322
Device Sequence Number1
Product Code LXB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/25/2019,07/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/24/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number94771
Device Catalogue Number94771
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/25/2019
Distributor Facility Aware Date07/10/2019
Event Location Home
Date Manufacturer Received07/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 07/24/2019 Patient Sequence Number: 1
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