MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB ABUTMENT SNAP COUPLING 5.5MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number 90305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on september 27, 2018.(b)(4).

Event Description

It was reported that the patient experienced skin overgrowth and infection at the abutment site.The patient underwent skin revision on (b)(6) 2018.Subsequently, the abutment was removed and a longer abutment was placed.

• Brand Name: ABUTMENT SNAP COUPLING 5.5MM
• 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; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7913348
• MDR Text Key: 121848675
• Report Number: 6000034-2018-01940
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K955713
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90305
• Device Catalogue Number: 90305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Date Manufacturer Received: 09/19/2018
• 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