MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-14 for PROVOX XTRAFLANGE 22.5 7275 manufactured by Atos Medical Ab.
[5283618]
Patient report to hospital that when they coughed out the xtraflange it was broken. The patient uses a provox activalve strong 4. 5mm voice prosthesis with a provox xtraflange. Nature of complaint details provided by the sales rep for the area are as follows: patient reported that the xtraflange broke when it was coughed out and they were cleaning it, flange is discoloured and distorted. According to the local rep for the hospital the patient also uses a kapitex stoma stud.
Patient Sequence No: 1, Text Type: D, B5
[12754620]
Investigation: the xtraflange is completely overgrown with biofilm, most likely candida. The biofilm has damaged the product to the extent that the product is very fragile. Additionally, the safety medallion has been cut within the outer diameter of the xtraflange, creating a weak spot and that is where the break has occurred. Conclusion: no product error has been found. The growth of biofilm on the product should be monitored more closely by the caregiver. The vp needs to be monitored regarding candida growth and the same should apply for the xtraflange mounted on the vp. Problems related to candida overgrowth is not addressed in the provox xtraflange ifu, but is addressed in the provox activalve ifu in section 2. 5 device lifetime: "the prosthesis is not a permanent implant, and requires periodic replacement. Depending on individual biological circumstances the device life varies, and it is not possible to predict the integrity of the device over a longer period of time. The prosthesis and especially the silicone material of the device will be affected by e. G. Bacteria and candida, and the structural integrity of the device will eventually deteriorate. Indications for replacement of the provox activalve voice prosthesis include leakage through the valve, blockage of the prosthesis, bacterial and candida overgrowth leading to degradation of the materials and/ or excessive pressure needed to obtain speech. " further, since the patient uses a stoma stud the xtraflange has most likely been torn when coming in contact with the stoma stud. It is advised to be careful when using this type of device since it can cause the xtraflange to dislodge from the vp when placing or removing the stoma stud. The issue is addressed in the provox xtraflange ifu in section precautions: "instruct the patient to be careful when cleaning the voice prosthesis and stoma, and when inserting devices such as larytubes and larybuttons into the stoma. Provox xtraflange may be accidently removed and aspirated. If this occurs the patient must seek immediate medical attention. " summary: the event was caused by clinician error when cutting the xtraflange in combination with massive candida overgrowth, which caused a weakening of the device. This caused the device to break, probably when being dislodged by the stoma stud. All these events are covered in the instructions for use accompanying the products.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2014-00004 |
| MDR Report Key | 4416015 |
| Report Source | 07 |
| Date Received | 2015-01-14 |
| Date of Report | 2014-09-30 |
| Date Mfgr Received | 2014-09-09 |
| Date Added to Maude | 2015-02-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 KRAFTGATAN 8 |
| Manufacturer City | HORBY, SE-242 2 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX XTRAFLANGE 22.5 |
| Generic Name | ADDITIONAL VOICE PROSTHESIS FLANGE |
| Product Code | EWL |
| Date Received | 2015-01-14 |
| Returned To Mfg | 2014-09-24 |
| Model Number | 7275 |
| Catalog Number | 7275 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-14 |