MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-07-15 for PROVOX LARYTUBE 9/55 WITH RING 7627 manufactured by Atos Medical Ab.
[2043417]
The pt stated that her tube was yellow in appearance and she did clean it with someone else's brush and peroxide. The back end of the tube broke off and she started coughing, she had shortness of breath and pain in her side so she went to the emergency room to get an x-ray and a mri, both was negative. The pt had probably coughed it out.
Patient Sequence No: 1, Text Type: D, B5
[9234016]
When examining the larytube it was definitely warned out and a big piece was missing in the top of the tube. The product has been exposed to severe damage. There are deep "channels" inside the tube. It is unclear what kind of brush that have been used as well as what kind of peroxide. According to the ifu the larytube should be cleaned with soft sponge of soft-bristled brush in hot water-soap solution and the examined tube has definitely not been cleaned according to ifu and that has caused the damage to the tube. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2011-00001 |
| MDR Report Key | 2189666 |
| Report Source | 99 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-06-30 |
| Date of Event | 2011-06-12 |
| Date Mfgr Received | 2010-06-17 |
| Device Manufacturer Date | 2005-08-01 |
| Date Added to Maude | 2012-06-14 |
| 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 | FERENC DAHNER, MGR |
| 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 | 2011-07-15 |
| Returned To Mfg | 2011-07-14 |
| Model Number | 9/55 WITH RING |
| Catalog Number | 7627 |
| Lot Number | 0508093 |
| 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 HORBY 24222 SW 242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-15 |