MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-01-27 for PROVOX XTRAFLANGE 22.5 7275 manufactured by Atos Medical Ab.
[5428309]
According to the patient the two provox xtraflanges that were mounted on the voice prosthesis were coughed loose and aspirated. The provox xtraflanges were subsequently then coughed up and retrieved.
Patient Sequence No: 1, Text Type: D, B5
[12864711]
Investigation: both xtraflanges are undamaged, free from biofilm and not deformed. The inner diameter is measured and found to be within specification. Design verifications shows that a force of >2. 3n is required in order to pull off the xtraflange from the voice prosthesis. It is not possible to apply this amount of force to the xtraflange by coughing; the xtraflange is placed adjacent to the tracheal mucosa and will therefore not be exposed to forces created by coughing. The most likely scenario is that the provox xtraflange was dislodged by some type of wrong handling. Possibly due to an incorrect cleaning method? There is a precaution in the ifu regarding this. Additionally there were two provox xtraflanges mounted on the voice prosthesis. This is not intended use which is stated in the ifu, see below. Ifu: precautions - do not place more than one washer on the prosthesis. 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. Conclusion/action inform the patient and clinician of the importance of following the instructions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2015-00003 |
| MDR Report Key | 4454473 |
| Report Source | 07 |
| Date Received | 2015-01-27 |
| Date of Report | 2015-01-07 |
| Date of Event | 2014-12-24 |
| Date Mfgr Received | 2015-01-07 |
| Date Added to Maude | 2015-03-03 |
| 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 | 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX XTRAFLANGE 22.5 |
| Generic Name | SILICONE WASHER |
| Product Code | EWL |
| Date Received | 2015-01-27 |
| Returned To Mfg | 2015-01-12 |
| Model 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 | 2015-01-27 |