MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93357

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 09/19/2020

Event Type  Injury  

Manufacturer Narrative

This report is submitted on october 8.2020.

Event Description

Per the surgeon, the patient experienced skin overgrowth that was treated with oral and topical antibiotics.The implant remains in-situ.

Manufacturer Narrative

It has now been reported that the abutment was removed under a general anaesthetic.This report is submitted on november 13, 2020.

Event Description

It has now been reported that the abutment was removed under a general anaesthetic.

• Brand Name: BA300 ABUTMENT 12MM
• 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: 10646563
• MDR Text Key: 210366232
• Report Number: 6000034-2020-02719
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502033435
• UDI-Public: (01)09321502033435(10)COH1061866(17)11232021
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/13/2020,10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2021
• Device Model Number: 93357
• Device Catalogue Number: 93357
• Device Lot Number: COH1061866
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2020
• Distributor Facility Aware Date: 10/21/2020
• Date Report to Manufacturer: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR