MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; AIRWAY DEVICE CLEANING BRUSH, INVASIVE

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2017

Event Type  malfunction  

Event Description

We have received a complaint from (b)(6) regarding a broken provox brush.(b)(4) stated that a patient was using a very old brush and patient states that the tip of brush broke off and fell into trachea.Atos medical is trying to get more information to describe the event.

• Brand Name: PROVOX BRUSH
• Type of Device: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• Manufacturer Contact: karolina nilsson ; kraftgatan 8; horby, SE-24-222 ; SW SE-24222 ; 641519800
• MDR Report Key: 6459903
• MDR Text Key: 72095028
• Report Number: 8032044-2017-00004
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1