MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-03-13 for PROVOX VEGA 8131 manufactured by Atos Medical Ab.
[5628441]
Suddenly speaking problems occurred. Patient checked vp in mirror and noticed that it was broken. Since the visible part of the vp was broken/torn off and almost fell into the trachea, he himself drew out the vp immediately.
Patient Sequence No: 1, Text Type: D, B5
[12977803]
This report is a correction of 8032044-2015-00004 which by mistake was classified as a 5 day report. Investigation: the vega has an xtraflange mounted. It is actually the esophagus flange that is ruptured (not visible to the patient). The tracheal flange is undamaged. The complaint description does not match the damage on the voice prosthesis. The esophagus flange is ruptured about 80% of the circumference, about 20% is still attached, no parts are missing. The fraction surface does not have any enclosed air bubbles that could have caused the tracheal flange to rupture. There are some nicks and scratches indicating that the outside of the housing has been in contact with a sharp tool of some kind. A possible scenario is that wrong method and/or tool was used while mounting the xtraflange and causing the scratch on the housing and at the same time an indication of fraction on the esophagus flange as well. This fraction then resulted in a ruptured esophagus flange at the time of removal of the voice prosthesis. The blue ring is still safely attached to the waist of the prosthesis. Conclusion: judged from the complaint description, damage on the housing and the surface of the rupture it is not likely that this rupture is a result of a faulty product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2015-00005 |
| MDR Report Key | 4598202 |
| Report Source | 07 |
| Date Received | 2015-03-13 |
| Date of Report | 2015-02-09 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2015-04-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 2 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-03-13 |
| Returned To Mfg | 2015-02-02 |
| Catalog Number | 8131 |
| Lot Number | 1409045 |
| Device Expiration Date | 2019-08-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-13 |