MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-08-27 for PROVOX LARYTUBE UNK manufactured by Atos Medical Ab.
[1383789]
The pt uses a provox larytube and has also a provox voice prosthesis. Due to leakage around the voice prosthesis, the doctor had placed a silicone washer (provox xtraflange) on the tracheal side of the prosthesis. Three days after insertion, the pt lost the xtraflange when coughing the mucus. She observed the flange on her tissue. An endoscopy was made to make sure that the xtraflange had been coughed out.
Patient Sequence No: 1, Text Type: D, B5
[8752539]
The pt very frequently removes her larytube during the day. During removal of the larytube, the larytube has caught on to the voice prosthesis so that the xtraflange has been torn off or dislocated from the voice prosthesis. The pt then coughed out the xtraflange. The instructions for use for larytube clearly warns that the larytube must not hook on to the voice prosthesis when used together. The doctor and pt has been informed about the importance of choosing an appropriate size of layrtube so it does not hook on to the voice prosthesis and that the device should be inserted and removed in a gentle manner in order not to dislocate the voice prosthesis or any accessory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2010-00003 |
| MDR Report Key | 1827552 |
| Report Source | 99 |
| Date Received | 2010-08-27 |
| Date of Report | 2010-08-25 |
| Date of Event | 2010-07-10 |
| Date Mfgr Received | 2010-08-04 |
| Date Added to Maude | 2011-04-28 |
| 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 | FERENC DAHNER, MANAGER |
| Manufacturer Street | PO BOX 183 |
| Manufacturer City | HORBY SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX LARYTUBE |
| Generic Name | TUBE, LARYNGECTOMY |
| Product Code | ESE |
| Date Received | 2010-08-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY 24222 SW 242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-08-27 |