MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; CLEANING BRUSH

Catalog Number 7204

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2017

Event Type  malfunction  

Manufacturer Narrative

This is an initial and final report in one.The device has not been returned from the reporter so a thorough investigation cannot be conducted.A theoretical evaluation can however be done and our conclusion is that the device has been used beyond its expected lifetime or used without adhering to the guidelines in the ifu of inspecting prior to use, not bending the brush repetitively and to discard when worn.Brush and part discarded by user.

Event Description

This is the information that was received from the atos medical local representative: the patient reports that she aspirated the metal/brush part of the tep brush while cleaning her tep.She reports it being in the lumen of the tep and when she pulled it out the metal part with the bristles fell off of the brush and into her airway.She reported that the brush was given to her by her slp ((b)(6)) approximately 2 mos.Prior to the event.She leaned over and was able to cough this piece of the brush out of her airway.None of the parts were kept to be evaluated.The slp does have the lot number and the packs of brushes she recently ordered.

• Brand Name: PROVOX BRUSH
• Type of Device: CLEANING BRUSH
• 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: 6676284
• MDR Text Key: 78671099
• Report Number: 8032044-2017-00009
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 7331791000775
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Speech Therapist
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 7204
• Device Lot Number: 1604001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/19/2017
• Device Age: 1 YR
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1