MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB COCHLEAR¿ VISTAFIX® VXA300 HEALING ABUTMENT; COCHLEAR BAHA VISTAFIX SYSTEM

Model Number 92998

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on november 10, 2021.

Event Description

Per the clinic, the patient experienced an infection and skin irritation on the abutment site (specific date not reported) and subsequently, was placed under general anesthesia on (b)(6) 2021, in order to remove the abutment.It was reported that the patient was treated with oral and topical antibiotics (specific date and duration not reported).

• Brand Name: COCHLEAR¿ VISTAFIX® VXA300 HEALING ABUTMENT
• Type of Device: COCHLEAR BAHA VISTAFIX SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 12785120
• MDR Text Key: 280571291
• Report Number: 6000034-2021-03417
• Device Sequence Number: 1
• Product Code: FZE
• UDI-Device Identifier: 09321502021708
• UDI-Public: (01)09321502021708(10)186519(17)241206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2021

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: 92998
• Device Catalogue Number: 92998
• Device Lot Number: 186519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/10/2021
• 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
• Patient Sex: Male