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

Model Number ASKU

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Host-Tissue Reaction (1297)

Event Date 10/25/2019

Event Type  Injury  

Event Description

Per the clinic, the patient underwent revision on (b)(6) 2019, in order to excise skin at the implant site.Revision surgery was successful and the implanted device remains insitu.

• Brand Name: NI
• 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
• MDR Report Key: 9435198
• MDR Text Key: 169795953
• Report Number: 6000034-2019-02670
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2019,11/15/2019

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 Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Distributor Facility Aware Date: 11/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR