MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-30 for PROVOX BRUSH 7204 manufactured by Atos Medical Ab.
[118752568]
Investigation: the inspection of the brush was done under a microscope. All parts of the brush are available for investigation. The complaint report states that there was no harm to the user. Therefore we conclude that no medical intervention was required. The wire of the brush-head is broken. The bristles of the device are heavily worn (photos are available at the manufacturer). The bristles are destroyed and lying down, and have not been suitable to perform their function for some time. This indicates that the brush has been used for a longer period of time. Both of the twisted steel wires are broken, almost at the same place. No deformations or clamp marks that could have caused the breakage was found. This indicates that the breakage is not due to any failure in the wire material since the twisted wire is made of stainless steel and unlikely to break at same place. However, it is possible to break the wire if the brush head is bent back and forth at least 10 times (we tried to break of the head of 4 new brushes by bending it back and forth and it took 13 movements on average). The pp-plastic of the handle is deformed around the metal wire. This is not the case for a new brush and this also indicates that the brush head was bent. In the ifu for provox brush there is a warning picture showing that bending the brush head is prohibited. Conclusion of investigation: no material failure was found. The twisted metal wires of the brush have been broken off at same place. This cannot happen unless the wire was bent several times. The ifu states that it is prohibited to bend the brush on the metal wire. The damage to the product is most likely caused by wrong handling of the product and use beyond its expected lifetime. Reporting: during the initial assessment the complaint was classified as not reportable to authorities. This assessment was based on the fact the event was solely a result of use error, according to? 2. 6 medical device reporting for manufacturers issued nov 8, 2016. After investigation and searches in the internal complaint database it showed that broken tip has previously been aspirated by a patient and medical intervention was require to remove the tip from the lung. With this knowledge it was decided to report this event despite the fact there was no harm to the patient in this case. As a consequence, this event is reported outside the set time frame for reporting to authorities. This is an initial and final report in one.
Patient Sequence No: 1, Text Type: N, H10
[118752569]
This is the information that was received from the initial reporter: according to customers in the normal, regular cleaning of the voice prosthesis - breaking off of the brush head. No damage to the customer! Lot incomprehensible. 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 | 8032044-2018-00002 |
| MDR Report Key | 7832494 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-30 |
| Date of Report | 2018-07-11 |
| Date Mfgr Received | 2018-07-11 |
| Date Added to Maude | 2018-08-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS KAROLINA NILSSON |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | H 24222 |
| Manufacturer Country | SW |
| Manufacturer Postal | 24222 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | KRAFTGATAN 8 |
| Manufacturer City | H |
| 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 | 2018-08-30 |
| Returned To Mfg | 2018-07-31 |
| Catalog Number | 7204 |
| Lot Number | UNKNOWN |
| 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 | KRAFTGATAN 8 H?RBY, 24222 SW 24222 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-30 |