MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for PROPHY PEARLS manufactured by Kaltenbach & Voigt Gmbh.
[61540009]
The dental "air polishing" blast media called "prophy pearls" that we had been using with no ill effects was reordered and it came to us with a highly concentrated ammonia odor. We sent that order back to kavo and ordered more. The second order smelled the same way when the container was first opened, so again we did no use it and sent it back. We then ordered the product one more time and again it came in heavy with ammonia. Kavo apparently made no attempts to correct this problem. They once said they would ship from another warehouse and we have not heard or seen anything to indicate that they honored that commitment. We also noticed that the pearls they sent were all expired. A phone call was made to kavo. They had told us that the powder does not expire. If it is true, then why does it have an expiration date on the package? In summary, a series of dental products were shipped to us heavily contaminated with ammonia, which is toxic and if we were not smart enough to reject these products they would have caused harm to our pt population. They have ignored our efforts to communicate the problem. Maybe you can do better. Diagnosis or reason for use: clean plaque off of pt's teeth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066482 |
| MDR Report Key | 6144344 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-23 |
| Date of Event | 2016-08-26 |
| Date Added to Maude | 2016-12-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROPHY PEARLS |
| Generic Name | PROPHY PEARLS |
| Product Code | EJR |
| Date Received | 2016-12-01 |
| Returned To Mfg | 2016-09-28 |
| Lot Number | 592851 |
| Device Expiration Date | 2016-05-09 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Brand Name | PROPHY PEARLS |
| Generic Name | PROPHY PEARLS |
| Product Code | EJR |
| Date Received | 2016-12-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Brand Name | PROPHY PEARLS |
| Generic Name | PROPHY PEARLS |
| Product Code | EJR |
| Date Received | 2016-12-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | KALTENBACH & VOIGT GMBH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-01 |