MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA DIVINO BLONDE; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90500

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Patient details unavailable at the time of this report, this report is submitted on (b)(6) 2017.

Event Description

It was reported that the rechargeable battery is leaking fluid.The patient has been advised to discontinue use of the battery and return it to the manufacturer for evaluation.There was no allegation of serious injury associated with the issue.Replacement equipment was sent to the patient.The rechargeable battery has not been returned as of the date of this report.

Manufacturer Narrative

Correction: the initial mdr submitted on may 24, 2017 was filed inadvertently.The rechargeable battery was a disposable battery that was not a cochlear manufactured product.

• Brand Name: BAHA DIVINO BLONDE
• 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; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6586701
• MDR Text Key: 75814764
• Report Number: 6000034-2017-00993
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K042017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90500
• Device Catalogue Number: 90500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention