MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-10-10 for PROVOX VEGA XTRASEAL 7782-01 manufactured by Atos Medical Ab.
[56920528]
This event is reportable because in the event of reoccurrence, the device could fall into the trachea with risk for clinical complications. Investigation: the voice prosthesis was not returned, an investigation of the product was therefore not possible. Based on the information given, there is no good reason to believe there has been something wrong with the product. However; it cannot be excluded that the products may have been damaged during the insertion. Discussion: a dislodged prosthesis is most often related to the quality of the fistula. E. G. A fistula that is created with a scalpel can become keyhole shaped. A weak or miss-shaped fistula 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. Miss-shaped fistulas that need short prostheses have a higher risk of suffering this problem. The design of the flanges is made so that retention force on the esophagus flange is significant larger than for the tracheal flange. This has been done to prevent the prosthesis ending up in the trachea. Conclusion/action: there is no reason to believe that the dislodged prosthesis is due to product fault. The ifu describes what to look for if there could be a problem with the puncture. It is possible to use a vega xtraseal together with an xtraflange, which might give a better fixation of the device. Device is lost. Device will not be returned.
Patient Sequence No: 1, Text Type: N, H10
[56920529]
Patient uses the provox vega xtraseal voice prosthesis. Complaint description from local representative: "patient was walking through his house and realized his vp is missing. Told his wife he would drive himself to the hospital. Went to the hospital and they took x-rays and those came back negative not showing anything. Gave him paperwork to call his doctor if his condition worsened and sent him home. The wife contacted the slp (b)(6), who did a house call. He used some sort of red rubber piece that he cut off of something. The wife wasn't sure what it was, but it was used to temporarily plug the puncture hole. Was told a new rx will be sent over shortly for a provox 2 4. 5mm. I asked to verify and there is no clue as to what happened, why or where the xtraseal that became dislodged is at this point in time. Note: no product will be returned. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00011 |
| MDR Report Key | 6013490 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-10 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-02 |
| Date Mfgr Received | 2016-10-03 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2016-10-10 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA XTRASEAL |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-10-10 |
| Catalog Number | 7782-01 |
| Lot Number | 1601162 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 11 MO |
| 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 | 2016-10-10 |