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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on december 21, 2017, (b)(4).

Event Description

Per the clinic, the patient experienced granulation tissue at abutment site and subsequently was treated with topical antibiotics, however the issue could not be resolved.Subsequently, the patient underwent revision surgery (date not reported) to remove granulation tissue.

Manufacturer Narrative

Per the clinic, the patient underwent an additional revision surgery on (b)(6) 2018, in order to excise skin at the implant site.Following surgery, the wound has reported to have healed well.

• 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
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: bianca pries ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109
• MDR Report Key: 7136850
• MDR Text Key: 95446320
• Report Number: 6000034-2017-02362
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention