MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for PROVOX VEGA 8112-01 manufactured by Atos Medical Ab.
[44190489]
The device is being shipped from us to sweden for investigation. I will follow up on this initial report when the device has been investigated. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[44190490]
This is the information that has been given from the initial reporter to atos medical local representative: the posterior /esophageal flange of the voice prosthesis is partially ripped from the cylinder that connects to the tracheal flange of the voice prosthesis (provox vega). The event occurred at time of placement. A new vp was utilized. The damaged vp is available and will be sent for investigation.
Patient Sequence No: 1, Text Type: D, B5
[45240053]
Evaluation of the returned device shows evidence of improper use. A toothed hemostat has most likely been used, causing indications for fracture in the silicone. The esophageal flange is fractured approximately 25% of the circumference. The instructions for use describes that non-toothed hemostats are to be used. A fractured esophageal flange may cause parts of the prosthesis to end up in the trachea if not discovered or if a total fracture occurs at the moment the prosthesis is pulled out of the te puncture. In this case the device was returned with all parts. The fracture was discovered during insertion why another prosthesis was inserted. The patient may have experienced discomfort due to a prolonged procedure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[45240054]
This is the information that has been given from the initial reporter to atos medical local representative: the posterior /esophageal flange of the voice prosthesis is partially ripped from the cylinder that connects to the tracheal flange of the voice prosthesis (provox vega). The event occurred at time of placement. A new vp was utilized. The damaged vp is available and will be sent for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00003 |
| MDR Report Key | 5595742 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-03-23 |
| Report Date | 2016-04-20 |
| Date Reported to Mfgr | 2016-04-20 |
| Date Mfgr Received | 2016-03-24 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-04-21 |
| 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 | 3 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-04-21 |
| Returned To Mfg | 2016-05-10 |
| Catalog Number | 8112-01 |
| Lot Number | 1508132 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-04-21 |