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 Problem Irritation (1941)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 10, 2018, (b)(4).

Event Description

Per the audiologist, it was reported that the patient experienced irritation and blood at the abutment site and subsequently was administered a topical antibiotic on (b)(6) 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 Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7771254
• MDR Text Key: 116698148
• Report Number: 6000034-2018-01677
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022712
• UDI-Public: (01)09321502022712(10)COH1109542
• 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
• Report Date: 08/01/2018

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: 93331
• Device Catalogue Number: 93331
• Device Lot Number: COH1109542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/10/2018
• 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
• Patient Age: 19 YR