MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-11 for PROVOX BRUSH 7204 manufactured by Atos Medical Ab.
[147623590]
Investigation: no product is returned yet. Therefore, the investigation is not started. Atos medical (b)(4) has asked for photos of the brush and the photos has been received by atos medical (b)(4). An initial preliminary analysis is performed and it point towards misuse of the products. A more thorough investigation will follow as soon as we receive the actual products. Information and conclusion from the investigation will be summarized in a follow up report. Initial preliminary analysis: the metal wire of both brushes show signs of bending where the wire meets the pp-handle of the brush. The remains of the wire sticking out of the pp-handle do not point straight upwards but sideways in an angle of around 45 to 60 degrees. This proves that the brush head has been bent, which is clearly prohibited by the user-ifu. Furthermore both brushes show signs of extended use. The nylon-filaments of the brush are worn out and laying down, indicating usage of the brush over a long period of time, likely longer than the recommended period of use stated in the user-ifu (1 month). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[147623591]
This is the information that was received from the initial reporter: clinician reported - patient was using the brush to remove a mucus plug and the brush tip fell off into the trachea. Patient was able to remove with tweezers. Description of the product: provox brush is a device intended for cleaning of provox voice prosthesis in-situ. Cleaning is recommended twice a day and after each meal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8032044-2019-00001 |
| MDR Report Key | 8503135 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-12 |
| Date Facility Aware | 2019-03-12 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-04-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8, P:O: BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | 24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8, P.O. BOX 183 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24222 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVOX BRUSH |
| Generic Name | AIRWAY DEVICE CLEANING BRUSH, INVASIVE |
| Product Code | LRC |
| Date Received | 2019-04-11 |
| Returned To Mfg | 2019-04-10 |
| Catalog Number | 7204 |
| Lot Number | 1807006 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | KRAFTGATAN 8, P.O. BOX 183 H?RBY, SWEDEN 24222 SW 24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |