MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM

Model Number 93332

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Purulent Discharge (1812); Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient experienced healing issues at the implant site, resulting in purulent discharge from the site. Subsequently, the patient applied a topical antibiotic to the site and the symptoms subsided (date not reported).

• Brand Name: BIA400 IMPLANT 4MM W ABUTMENT 12MM
• 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
• MDR Report Key: 8978451
• MDR Text Key: 157040117
• Report Number: 6000034-2019-01744
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 09/10/2019,08/27/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/10/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: 93332
• Device Catalogue Number: 93332
• Device LOT Number: ASKU
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2019
• Event Location: Other
• Date Report TO Manufacturer: 09/10/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 09/10/2019 Patient Sequence Number: 1