MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for PROVOX2 7217 manufactured by Atos Medical Ab.
[186617694]
Investigation: no device was available for investigation. Users story: first vp change after 23 months, provox2 8mm. Changed due to periprosthetic leak (leakage around the vp). Second vp change after 26 months, provox2 8mm. Changed due to periprosthetic leak. Third vp change after 12 months. Changed due to periprosthetic leakage. This time a provox2 6mm was placed. After 7 months the too short vp caused necrosis to the party wall. In the instructions for use we describe how to decide on vp lengths. Conclusion: based on the user story in the case report, atos medical ab believes it is clear that this adverse advent does not originated from a faulty product.
Patient Sequence No: 1, Text Type: N, H10
[186617695]
This is the information that was received from the initial reporter: clinical affairs within atos medical ab did an expanded search during regular cer update and found a case study in india regarding provox2. The case study was about a patient that had a too short prosthesis fitted, which resulted in pressure necrosis of the part wall and mucosa between the flanges. Case study: anam jr, kannan s, chaukar da, d'cruz a k. A rare case of tracheoesophageal puncture with party wall necrosis. Indian j cancer. 2015 jul-sep;52(3):303-4. Intended use and description of the product: the provox 2 voice rehabilitation system is intended for use in surgical, prosthetic voice restoration after total laryngectomy. The prosthesis may be inserted by the physician at the time of the total laryngectomy (primary puncture), or at a later date (secondary puncture), or may be used to replace the present prosthesis. The provox2 voice prosthesis is a sterile single use one-way valve that keeps a te-puncture open for speech, while reducing the risk of fluids and food entering the trachea. It is made of medical grade silicone rubber and radio-opaque fluoroplastic. The prosthesis is not a permanent implant and needs periodic replacement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2020-00002 |
| MDR Report Key | 9841209 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-03-17 |
| 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 | 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 | 3 |
| Brand Name | PROVOX2 |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2020-03-17 |
| Catalog Number | 7217 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-17 |