MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-20 for PROVOX ACTIVALVE LIGHT 6 MM 7151 manufactured by Atos Medical Ab.
[70455463]
Investigation: the investigation shows that the safety strap is intact and the silicone material of the housing has been stressed close to the esophagus flange at the hinge side. The flat surface of the entrance opening of the loading tube is deformed and a have a dome shape compared to an undamaged tube. The fact that the valve flap is dislodged from the blue ring is most likely a result from a non-forward folding of the voice prosthesis esophagus flange. These observations indicate that abnormal stress has been applied to material and components. Conclusion/action: it is very unlikely that the insertion is performed according to the ifu based on the observations above. The clinician should be instructed to follow the ifu to secure a proper handling when inserting the activalve. Trend analysis: trend for this issue is judged as stabile. A more extensive analysis is done twice a year for the management review. Corrective and preventive action: no product fault, no reason for corrective or preventive actions. Patient risk associated with this complaint is considered negligible based on the fact that all parts were returned.
Patient Sequence No: 1, Text Type: N, H10
[70455464]
This is the information that was received from the atos medical local representative: when the doctor inserted the activalve with the patient, the entire blue inside (including the valve) let loose and fell. The doctor could reach for it with a tweezer, before it had a chance to fell into the patient lungs. Our product specialist was there and watched the insertion and everything was done according the ifu. They had to make a ct scan and mri, to check where his previous voice prosthesis was (probably swallowed it), so they could immediately check if really nothing fell into the lungs. After this another activalve was placed and there were no problems. Device has been returned and investigated. (b)(6) 2017
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2017-00002 |
| MDR Report Key | 6416662 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-20 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-28 |
| Date Mfgr Received | 2017-03-02 |
| Device Manufacturer Date | 2016-08-23 |
| Date Added to Maude | 2017-03-20 |
| 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. KAROLINA NILSSON |
| 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 | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX ACTIVALVE LIGHT 6 MM |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2017-03-20 |
| Returned To Mfg | 2017-03-03 |
| Catalog Number | 7151 |
| Lot Number | 1608166 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8 HORBY, SE-24222 SW SE-24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-20 |