MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-17 for PROVOX VEGA 8123 manufactured by Atos Medical Ab.
[45292376]
Evaluation of the returned device shows spots of biofilm formation, most likely candida, on the sealing surface of the valve flap close to the valve hinge. The biofilm prevents the flap from closing, thus causing the leakage. Every voice prosthesis is tested for opening pressure during manufacture to ensure that all voice prostheses performs to specification when delivered. Leakage due to biofilm growth is not considered a product error. The intensity of biofilm growth into the voice prosthesis material varies depending on numerous factors such as food/drinking habits, usage of antibiotics, cleaning with brush/flush, ongoing candida infection, and more. Trouble shooting is included in the instructions for use as well as the instruction to plug the prosthesis and seek medical attention should leakage occur. However, as this unfortunate patient needed treatment for pneumonia which may have been caused by the device the event is reported.
Patient Sequence No: 1, Text Type: N, H10
[45292377]
The voice prosthesis started to leak through the centre within 5 days of placement. The patient had to be treated by the family doctor for pneumonia/chest infection with antibiotics. When the patient arrived in clinic, attempts were made to clear the prosthesis in order to deal with the leakage - but the expected resistance from the valve flap was not encountered, and the prosthesis was replaced. Once removed it was examined outside the patient and the valve flap was found permanently open. The patient received a new voice prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00005 |
| MDR Report Key | 5658812 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-17 |
| Date of Report | 2016-05-16 |
| Date of Event | 2016-03-22 |
| Date Mfgr Received | 2016-04-17 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-05-17 |
| 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 |
| Reporter Occupation | SPEECH THERAPIST |
| 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 | KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-24222 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX VEGA |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-05-17 |
| Returned To Mfg | 2016-05-10 |
| Catalog Number | 8123 |
| Lot Number | 1503056 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2016-05-17 |