MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2007-10-10 for PROVOX BRUSH 7204 manufactured by Atos Medical Ab.
[722301]
During a pt meeting in another country, a pt informed our rep that he some time ago had some lung problems and went to see a doctor. X-ray revealed a provox brush in the lung which consequently was removed. The pt did not feel any discomfort afterwards. Our rep forwarded the info to us as a complaint.
Patient Sequence No: 1, Text Type: D, B5
[7877604]
Instructions for use have been examined and correct handling is clearly described. In order to drop the brush into the trachea, it must be used completely in violation with the instructions for use. The hospital has done the same assessment of the event and they have not reported it to the authorities. The pt has been informed on correct use of the brush. Case has been closed. This event was not initially reported as an mdr. Due to incident report 6/29/2007, (mfr #8032044-2007-00009) review of former similar events was done and we decided to report this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2007-00016 |
| MDR Report Key | 924691 |
| Report Source | 04,07 |
| Date Received | 2007-10-10 |
| Date of Report | 2007-10-30 |
| Date of Event | 2006-06-30 |
| Date Mfgr Received | 2006-07-04 |
| Device Manufacturer Date | 2005-02-28 |
| Date Added to Maude | 2007-11-29 |
| 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 |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 41519800 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX BRUSH |
| Generic Name | CLEANING BRUSH FOR VOICE PROSTHESIS |
| Product Code | EPE |
| Date Received | 2007-10-10 |
| Model Number | PROVOX BRUSH |
| Catalog Number | 7204 |
| Lot Number | 0502005 (UNCERTAIN) |
| Device Expiration Date | 2010-01-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 905989 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-10 |