MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93332

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Inflammation (1932); Skin Infection (4544)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 12, 2022.

Event Description

Per the clinic, the patient experienced inflammation, crusting and pus seeping from the abutment site.Treatment for the infection unknown.The implant remains in-situ.Further information is being sought from the clinic.

• Brand Name: BIA400 IMPLANT 4MM W 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: 14079489
• MDR Text Key: 289053273
• Report Number: 6000034-2022-01091
• Device Sequence Number: 1
• Product Code: MAH
• UDI-Device Identifier: 09321502022729
• UDI-Public: (01)09321502022729(10)COH1135369(11)12012017(17)11022022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2022
• Device Model Number: 93332
• Device Catalogue Number: 93332
• Device Lot Number: COH1135369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female