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

Catalog Number	7204
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CLEANING BRUSH
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 6676284
• Report Number: 8032044-2017-00009
• Device Sequence Number: 72817
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 7331791000775
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Speech Therapist
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 7204
• Device Lot Number: 1604001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/19/2017
• Device Age: 1 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1