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.
[57053812]
This report is related to report (b)(4) provox xtraflange us (mfr # 8032044-2016-00009) but as the event is different it is reported separately. Reportable because if the event would reoccur the device could fall into the trachea with risk for clinical complications. Investigation: neither the voice prosthesis nor 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 voiceprosthesis and xtraflange dislodged due to product malfunction. 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
[57053813]
Patient uses the provox vega voice prosthesis with an xtraflange accessory, in addition to a provox larytube. Complaint description: local representative was calling to follow up with the patient regarding a previous complaint (# (b)(4)). The patients wife rita stated that the patient is fine and after the incident they went home and could not find the xtraflange after looking everywhere for it. Within a day or so per the wife, the additional xtraflange and voice prostheses that was being used was then dislodged and coughed out by the patient into his hand. The patient called and went back into the facility and was seen by the slp again. He stated to the slp that it was his fault and he may have made it come loose and when coughing it became dislodged. The slp resized the patient and pt. Now has a new smaller size vp that is in place currently. Note: there is no product to return for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00010 |
| MDR Report Key | 6019828 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-10-12 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-09-16 |
| Date Mfgr Received | 2016-09-27 |
| 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 |
| Remedial Action | OT |
| 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 | 1603093 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Age | 6 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 | 2016-10-12 |