MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-25 for PROVOX LARYTUBE 9/36, FENESTRATED 7640 manufactured by Atos Medical Ab.
[60857524]
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.
Patient Sequence No: 1, Text Type: N, H10
[60857525]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00012 |
| MDR Report Key | 6127383 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-25 |
| Date of Report | 2016-11-25 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-28 |
| Date Added to Maude | 2016-11-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | SPEECH THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ELIN ALGOTSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-24222 |
| Manufacturer Phone | 641519800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX LARYTUBE 9/36, FENESTRATED |
| Generic Name | PROVOX LARYTUBE |
| Product Code | KAC |
| Date Received | 2016-11-25 |
| Catalog Number | 7640 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-25 |