MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-12 for PROVOX UNKNOWN manufactured by Atos Medical Ab.
[28045450]
Investigation: a portex tracheostomy tube intended for trach-patients was used on a laryngectomized patient that also was fitted with a provox voice prosthesis. As described in the article the patient was placing and removing the tracheostomy tube himself. As the product is not returned it is not possible to do any further investigations. Discussion: the designs of the flanges of the voice prosthesis are made so that the retention force of the esophagus flange is significant larger than for the tracheal flange. This design strategy is applicable for all our voice prostheses. This is made to prevent the prosthesis to end up in the trachea in case the puncture tissue is weak. However, if an external object not intended for a laryngectomized patient is used (as a ridged portex tracheostomy tube) in combination with allowing the patient himself handle this object there might be a risk that an edge of the object hitches to the voice prosthesis causing a dislodgement. Conclusion: a likely scenario described above, (and also in the article) is believed to have caused the incident. There is no reason to believe that the dislodged prosthesis is due to any product malfunction. (b)(6). Not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[28045451]
The following event was discovered through our post market procedure in a publication; a novel approach in the management of an aspirated voice prosthesis in a laryngectomized patient by (b)(6), 2014. A (b)(6) adult laryngectomized patient went to the er complaining of intractable cough resulting from the aspiration of the food contents through the tep puncture. Six months prior, he had undergone a total laryngectomy and primary voice prosthesis (provox1) insertion. He was intermittently using a noncuffed portex tracheostomy tube through his narrowed tracheostoma examination on removal of the tracheostomy tube showed the absence of the voice prosthesis in the tep site. The patient was unaware of the missing prosthesis. He had the habit of self-insertion of the tracheostomy tube and the doctors presume that the prosthesis aspiration might have occurred during this maneuver. Xray confirmed the presence of the aspirated voice prosthesis in the right bronchus intermedius. A bronchoscopy revealed the voice prosthesis to be occluding the opening of the right middle and lower lobe bronchus. The voice prosthesis was removed using a laparoscopic biopsy forceps through the tracheostoma under topical anesthesia. The patient was discharged the following day with a plan to insert secondary voice prosthesis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2015-00007 |
| MDR Report Key | 5144452 |
| Date Received | 2015-10-12 |
| Date of Report | 2015-10-08 |
| Date Mfgr Received | 2015-09-28 |
| Date Added to Maude | 2015-10-12 |
| 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 | 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 22 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROVOX |
| Generic Name | LARYNGEAL VOICE PROSTHESIS |
| Product Code | EWL |
| Date Received | 2015-10-12 |
| Model Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 KRAFTGATAN 8 HORBY, SE-242 22 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-12 |