MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for PROVOX VEGA 8133 manufactured by Atos Medical Ab.
[42888796]
The esophagus flange is ruptured about 80% of the circumference, no parts are missing. The blue ring of the voice prosthesis shall be circular when seen from the esophagus side. The ring of the returned voice prosthesis is deformed; it is shaped as the letter "d". This deformation is most likely caused by a wrongly performed insertion/reload. Conclusion/action judged from the damage on the flange and blue ring this is not a result of a faulty product. The device failure is most likely caused by abnormal use during the insertion procedure. Corrective and preventive action: no product fault, corrective or preventive actions are not considered necessary except from informing the customer of the importance of following the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
[42888797]
During insertion procedure the clinician found that the esophageal flange of the voice prosthesis was torn and barely connecting with the shaft of the prosthesis. The event was discovered when the prosthesis came out of the loading tube at the end of the insertion. The prosthesis was removed right away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00002 |
| MDR Report Key | 5554083 |
| Date Received | 2016-04-07 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-02-28 |
| Date Mfgr Received | 2016-03-03 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2016-04-07 |
| 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 | 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 | 0 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-04-07 |
| Returned To Mfg | 2016-03-18 |
| Catalog Number | 8133 |
| Lot Number | 1511114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-04-07 |