MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-12 for PROVOX XTRAFLANGE 7276 manufactured by Atos Medical Ab.
[57053363]
Investigation: neither the voice prosthesis or xtraflange has been returned; investigation of products is therefore not possible. Although we have not been able to examine if the details had any damages, there is no reason to believe that the xtraflange has dislodged due to a faulty product. However; it cannot be excluded that the products may have been damaged during the insertion. Discussion: a leakage around the puncture is most often related to the quality of the puncture. E. G. A puncture that is created with a scalpel can become keyhole shaped. This is avoided if a vega puncture set is used. A weak or miss-shaped puncture gives less retention force towards the voice prosthesis t-flange and e-flange. This means that the voice prosthesis will be more prone to dislodge. Conclusion/action: based on the fact that an xtraflange is used, we assume that this patient has had some kind of issue with the puncture and problem with leakage around the prosthesis. It is possible to use a vega xtraseal together with an xtraflange, which might give a better fixation of the device.
Patient Sequence No: 1, Text Type: N, H10
[57053364]
Patient uses the provox vega voice prosthesis with an xtraflange accessory, in addition to a provox larytube. The patient woke up in the morning and his wife was cleaning the larytube and had noticed part of the flange was exposed and not fully around the vp. She called the patients slp and made appointment to go in and be seen, they said to come in and they would have that fixed. About an hour later the wife decided to take another look and the xtraflange "was gone" was the way she described it. They went into the slp and a chest x-ray was done, it came back negative with nothing showing up. The patient indicated he feels fine and isn't experiencing any symptoms or strange feelings and didn't seem too concerned about it missing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00009 |
| MDR Report Key | 6019699 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-12 |
| Date of Report | 2016-10-05 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2016-09-12 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2016-10-12 |
| 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 | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 22 |
| 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 XTRAFLANGE |
| Generic Name | VOICE PROSTHESIS (ACCESSORY) |
| Product Code | EWL |
| Date Received | 2016-10-12 |
| Catalog Number | 7276 |
| Lot Number | 1509026 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 22 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-12 |