MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93331

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Cellulitis (1768)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the surgeon, the patient experienced an infection, recurrent cellulitis and granulation tissue at the abutment site.The patient was treated with antibiotics (type and date); however the issue could not be resolved.Additional information has been requested; however has not been made available as of the date of this report.

Manufacturer Narrative

It was reported that the patient was treated with steroid injections.Following treatement the issues have reportedly resolved.This report is submitted on october 26, 2018.

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 10MM
• 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 (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7941736
• MDR Text Key: 123041168
• Report Number: 6000034-2018-02028
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)COH1129961(17)220701
• 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
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2022
• Device Model Number: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1129961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention