MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-19 for PROVOX LARYBUTTON 18/8 7674 manufactured by Atos Medical Ab.
[4298104]
This incident was reported to us (b)(4) 2014. Slp reported: it happened (b)(6) 2013, changed filter, aspirated the larybutton freaked out and tried to grab it and pushed it further. The wife tried to help with tweezers and pulled out prosthesis. On (b)(6), a redtube catheter was placed; on (b)(6) a new prosthesis was placed. They then performed a bronchotomy and retrieved the larybutton, removed in total. Patient was informed not to wear a larybutton without a tubeholder from here on out. Slp went over all the educational information again with the patient and his wife. Additional/ corrected information from our sales rep - (b)(4) who went and spoke with the slp in person (b)(4) 2014. 1. The patient didn't go into the or until the middle of the night. This is part of the reason that the days went from one to the next. Once he got to the hospital, they decided to wait until the next day to remove the larybutton. It wasn't causing immediate breathing difficulty. 2. According to the patient's report and the slp today, the patient had folded the larybutton in half to make it easier to insert. This is common for those that use the button. When he went to insert it, he coughed and then breathed the larybutton in at the same time. He then made it go into his stoma and out of reach for himself with further attempts to remove it. This is when he went to the hospital. 3. There were no modifications to the larybutton. 4. He was not wearing laryclips or a tubeholder as the original fitting was such that it was a tight fit. Thus the need to fold it to place it in the stoma. 5. The slp told me today, that the patient is not compliant with what she has told him and recommended as he was wearing the larybutton last visit without the tubeholder or laryclips and she distinctly told him he was not allowed to wear it without one of those two options. The patient has been intermittently compliant with the things that have been recommended for his safety and best use of products.
Patient Sequence No: 1, Text Type: D, B5
[11573570]
Investigation: no product has been returned and can therefore not be investigated. Conclusion/action: based on the descriptions, the patient has used the larybutton without securing it with provox tubeholder or provox laryclip even if the slp has determined that there is a need for this. In the ifu it is described how to fold the device and several warnings and precautions regarding the issue. See extractions from instructions for use below. The patient has clearly not been following the slp? S advice on how to use the device, nor the instructions and warnings in the ifu. Additionally the device is a prescription device and, as stated in the ifu, it must always be evaluated if the larybutton is a suitable device for the patient. This should also be reevaluated; potential users of the provox larybutton must have sufficient cognitive ability, manual dexterity, and visual acuity to understand and follow the instructions for use. If you doubt in any way that your patient fulfills all of the above criteria, including that he or she has fully understood the information you have provided, do not prescribe the provox larybutton. Excerpt from the ifu clearly outlining the risks and how to safely insert and use the device: - if the product is pushed too far into trachea it may obstruct breathing. Always insert the larybutton according to the instructions in this ifu. Insert and remove the provox larybutton with caution insert or remove devices that you keep in the provox larybutton carefully while using one hand to keep the provox larybutton in place. Insertion: fold the tracheal end with your fingers as seen in figure 3, and hold it firmly folded. Insert the tracheal end into your tracheostoma and release the tracheal end (figures 4 and 5). Gently insert the provox hme system component that you intend to use. Potential users of the provox larybutton must have sufficient cognitive ability, manual dexterity, and visual acuity to understand and follow both the instructions for use *if you doubt in any way that your patient fulfills all of the above criteria, including that he or she has fully understood the information you have provided, do not prescribe the provox larybutton. Corrective action: advice the slp to evaluate if the larybutton really is a suitable product for this patient. Inform the patient about the importance of reading and follow the instructions for use. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2014-00002 |
| MDR Report Key | 3687862 |
| Report Source | 05,07 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-03-17 |
| Date of Event | 2013-12-09 |
| Date Mfgr Received | 2014-03-07 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2014-03-19 |
| 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 |
| 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 LARYBUTTON |
| Generic Name | TRACHEOSTOMY BUTTON |
| Product Code | KAC |
| Date Received | 2014-03-19 |
| Model Number | 18/8 |
| Catalog Number | 7674 |
| Lot Number | 1210122 |
| Device Expiration Date | 2017-09-30 |
| 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 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-19 |