MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-14 for PROVOX VEGA 17FR 6MM 8271 manufactured by Atos Medical Ab.
[179230555]
Investigation: the product has not yet been returned. Therefore, only a theoretical assessment is done so far. When the product is available for examination an investigation of the root cause of the event will be performed. Information and conclusion from the investigation will be summarized in a follow up report. During insertion the voice prosthesis is attached to an insertion pin and the prosthesis is also fastened with a safety strap to prevent the prosthesis from dislodgement during insertion. The initial theoretical investigation shows that if the safety strap was correctly attached (barb-fitting, the voice prosthesis safety strap completely through the hole of the inserter pin) it is impossible to separate the two by the flow gradient created by inhaling. Internal testing shows that an average force around 2. 3n is needed to separate insertion pin and voice prosthesis when it is safely attached. Internal testing also shows that it is possible to rotate the voice prosthesis 360 and -360 degrees axial movement back and forward in an artificial fistula and still the insertion pin is sufficiently attached to the prosthesis. Exemption number e2018017. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[179230556]
This is the information that was received from the initial reporter: the voice prosthesis would not stay on insertion stick. When attempting to place the voice prosthesis it came off the stick and when patient took a deep breath to cough the tail of the voice prosthesis came off the stick and the patient inhaled the voice prosthesis into his trachea. Patient coughed it right back up and was unaffected. Slp felt the stick was not sized correctly for the voice prosthesis. Description of the product: the provox vega voice prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). The provox insertion system is a sterile single use device intended for anterograde replacement of the provox vega voice prosthesis. This replacement procedure is carried out by a medical professional in accordance with local or national guidelines. The provox insertion system is not intended to be used for insertion of a voice prosthesis in a freshly made puncture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2019-00004 |
| MDR Report Key | 8699524 |
| Date Received | 2019-06-14 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-20 |
| Date Facility Aware | 2019-05-21 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2018-11-28 |
| Date Added to Maude | 2019-06-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8, P:O: BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | 24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8, P.O. BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX VEGA 17FR 6MM |
| Generic Name | LARYNGEAL PROSTHESIS |
| Product Code | EWL |
| Date Received | 2019-06-14 |
| Catalog Number | 8271 |
| Lot Number | 1812270 |
| Operator | HEALTH PROFESSIONAL |
| 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 | KRAFTGATAN 8, P.O. BOX 183 H?RBY, 24222 SW 24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-14 |