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 2016-05-18 for PROVOX 2 7219-04 manufactured by Atos Medical Ab.
[45402595]
Evaluation of the returned device shows spots of biofilm formation, most likely candida, on the valve flap and the esophagus flange. The biofilm prevents the flap from closing properly. Further, the device was returned in a rather dirty state, suggesting that it may have been insufficiently cleaned during use. Discussion: every voice prosthesis is tested for opening preassure during manufacture to ensure that all voice prostheses performs to specification when delivered. 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 if leakage should occur. Conclusion: leakage due to biofilm growth is not considered a product error. However, as this unfortunate patient experienced severe aspiration pneumonia which may have been caused by the device, the event is reported.
Patient Sequence No: 1, Text Type: N, H10
[45402596]
The following is a citation of the event description received from customer: "primary insertion of provox 2, size 10, after total laryngectomy in (b)(6) male patient (date of surgery (b)(6) 2016). Removal of ryle tube after one week and starting of oral feeding without any leakage. Two weeks later the patient return on the follow-up with severe aspiration pneumonia. By examination of the patient & the device we found that there is device failure with leaking through the device despite intact valve. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2016-00006 |
| MDR Report Key | 5662503 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-04-03 |
| Date Mfgr Received | 2016-04-19 |
| Device Manufacturer Date | 2015-04-01 |
| Date Added to Maude | 2016-05-18 |
| 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 | 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 2 |
| Generic Name | VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2016-05-18 |
| Returned To Mfg | 2016-05-16 |
| Catalog Number | 7219-04 |
| Lot Number | 1508130 |
| 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 | 2016-05-18 |