MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2007-04-05 for PROVOX LARYBUTTON LARYBUTTON 8MM REF 7674 manufactured by Atos Medical, Ab.
[628675]
The pt was sitting in his car attempting to insert the product by viewing in the car interior mirror. Due to problem with his hands (the pt has large hands and missing his index finger), he folded the whole product and accidentally inserted the entire device into the trachea. While attempting to remove it, he lodged the product further down the trachea. With the assistance from a parking attendant, he was transported to a nearby hospital and the product was extracted under local anesthetics with an endoscopic foreceps. The time between the incident and the removal of the product was 45 minutes. The pt was discharged from the hospital directly after the procedure without complication.
Patient Sequence No: 1, Text Type: D, B5
[7928056]
The returned product was visually inspected. It could be observed that the "wings" of the product have been removed by the user. Please see examination report. Action: instructions for use will be clarified with the following text: warning: if the product falls into trachea, it may obstruct breathing. Always insert the larybutton according to the instructions in this manual. Do not cut off the wings or otherwise, mechanically modify the larrybutton since it will change outer diameter and mechanical stability of the product. Stn# b077060.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2007-00001 |
| MDR Report Key | 842264 |
| Report Source | 04,07 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-04-02 |
| Date of Event | 2007-03-12 |
| Date Mfgr Received | 2007-03-15 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-05-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FERENC DAHNER, MANAGER |
| Manufacturer Street | P.O. BOX 183 |
| Manufacturer City | HORBY SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX LARYBUTTON |
| Generic Name | TRACHEOSTOMA BUTTON |
| Product Code | ESE |
| Date Received | 2007-04-05 |
| Returned To Mfg | 2007-04-02 |
| Model Number | LARYBUTTON 8MM |
| Catalog Number | REF 7674 |
| Lot Number | 0606055 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 829477 |
| Manufacturer | ATOS MEDICAL, AB |
| Manufacturer Address | P.O. BOX 183 HORBY SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-05 |