MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-06-01 for PROVOX 2 10MM 7219-01 manufactured by Atos Medical Ab.
[76439136]
Investigation: there was no product returned for investigation. Discussion: the design of the voice prosthesis flanges are made, so that the retention force of the esophagus flange is significant larger than for the tracheal flange. This design strategy is applicable for all our voice prostheses and made to prevent the prosthesis to end up in the trachea in case of weak puncture tissue. Although it cannot be excluded, there is no reason to believe that the prosthesis has dislodged due to any product failure. Although the prosthesis fell into the upper airways in this case, it is more likely that the dislodging problem is related to something else. For example, if an external object may come in contact with the prosthesis (as a tube, an adhesive or a hme object) there might be a risk that the object hooks to the voice prosthesis causing dislodgement. A dislodgement of the prosthesis may also be related to the quality of the puncture. As an example, a fistula that is made with a scalpel becomes more keyhole-shaped than if a vega puncture sets is used. If a puncture is weak or miss shaped it can give less retention force towards the voice prosthesis t-flange and/or e-flange, which means that the prosthesis becomes more prone to dislodge. In this case it is most likely not a prosthesis problem, but a puncture problem. The puncture is not retaining the prosthesis sufficiently, it might have become wider, which can happen. For example because of reflux, diabetes, thyroid problems, stricture, general (oncologic) condition. The puncture problem needs to be addressed and the patient needs to see his physician and/or slp. They should assess the puncture and evaluate the patient for xtraseal. He will most likely also have leakage around, but may not have felt or realized it. Trend analysis: trend for this issue is judged as stabile. A more extensive analysis is done 2-times a year for the management review. Corrective and preventive action: since the product is missing, no product defect could be found. Inform user about the advantage with vega xtraseal, possibly supplemented with an xtraflange. Patient risk associated with this complaint is considered negligible based on the fact that all parts were returned. Device is not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[76439137]
This is the information that was received from the atos medical local representative: the patient was using flexiderm adhesive versus xtrabase. Sunday (b)(6) 2017 when the patient was at his granddaughter's softball game. He coughed and felt funny, so he left and went home where he realized the prosthesis popped out, when home he called and asked for his wife to come home stating something is wrong and the prosthesis is missing. She came home and saw it was not in the puncture, since this happened previously, they were told that if it popped out and became lodged in his lungs, he would begin coughing uncontrollable. That never happened, so they figured it wasn't anything to serious. They used a device given to them from the facility at (b)(6) where the patient is now being seen by a slp, to retrieve the prosthesis. They were able to retrieve the prosthesis and went in to (b)(6) to have the prosthesis replaced into the puncture. The prosthesis was retrieved and had not reached the lungs, it has dislodged from the original placement of the device. The facility stated to them that if the device went into the end user's lungs, he would be coughing uncontrollably, so the patient and his wife stated they knew it hadn't gone that far down and also stated they knew it wasn't that serious.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00006 |
| MDR Report Key | 6603923 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-06-01 |
| Date of Report | 2017-06-01 |
| Date of Event | 2017-05-07 |
| Date Mfgr Received | 2017-05-09 |
| Device Manufacturer Date | 2016-08-23 |
| Date Added to Maude | 2017-06-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAROLINA NILSSON |
| 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 2 10MM |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-06-01 |
| Catalog Number | 7219-01 |
| Lot Number | 1608292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 MO |
| 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 | 2017-06-01 |