MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LARYTUBE 9/36, FENESTRATED

Catalog Number 7640

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The device is being shipped from us to (b)(6) for investigation.I will follow up on this initial report when the device has been investigated.Kind regards, (b)(6) atos medical ab.

Event Description

This is the information that was received from the atos medical local representative: the patient reported to the clinician for a prosthesis placement and notified the slp that he was concerned that he could not find his larytube and thought he swallowed it.Upon inspection, it appeared that the tube was lodged in his trachea.Dr.(b)(6) removed the larytube without difficulty and it appeared that the patient removed the larger part of the larytube that is intended to prevent aspiration of the tube and house the hme.Upon removal, there was no evidence of distress.The surgeon, myself (b)(6) told the patient that you are not to remove the outer portion of the tube and he stated understanding.The damaged device is available and will be sent for investigation.

• Brand Name: PROVOX LARYTUBE 9/36, FENESTRATED
• Type of Device: PROVOX LARYTUBE
• 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: elin algotsson ; kraftgatan 8; horby, SE-24-222 ; SW SE-24222 ; 641519800
• MDR Report Key: 6127383
• MDR Text Key: 60857524
• Report Number: 8032044-2016-00012
• Device Sequence Number: 1
• Product Code: KAC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7640
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention