MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-05-09 for YOUNG DENTAL STANDARD POINTED PROPHY BRUSH - 090201 manufactured by Young Dental Manufacturing Co 1, Llc.
[44753254]
The dental office comingles their brushes, so we were unable to determine the lot or expiration date of the brush involved in this complaint. The dental office did send in a handful of brushes from the drawer where they comingle (lot and expiration also unable to be determined) for evaluation. During evaluation, we were unable to replicate the actual complaint when run on a handpiece per manufacturer's instructions. Some bristles were only able to be removed using considerable force and pliers. Due to a lack of information it can only be hypothesized that this event occurred due to the age of the brush, possibly an expired lot where the glue became brittle, or that an isolated event occurred where the brush in the complaint did not receive enough glue. No other complaints of this type have been received.
Patient Sequence No: 1, Text Type: N, H10
[44753255]
"sent from my iphone per (b)(6): patient (she) (b)(6)- used brush to get stain off- once in mouth bristles went everywhere - including eye- which patient went to eye dr. And dr. Said ok - dentist gave patient a credit- but says everything is fine- she has been in this bus 33 yrs never seen it before sending a few back in the mail does not have lot # and is in no way upset. I will send out replacement do not know since they mix them that had expired"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1941138-2016-00013 |
| MDR Report Key | 5641376 |
| Report Source | USER FACILITY |
| Date Received | 2016-05-09 |
| Date of Report | 2016-04-15 |
| Date Mfgr Received | 2016-04-13 |
| Date Added to Maude | 2016-05-09 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SARAH MOORE |
| Manufacturer Street | 13705 SHORELINE COURT E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal | 63045 |
| Manufacturer Phone | 3143440010 |
| Manufacturer G1 | YOUNG DENTAL MANUFACTURING CO 1, LLC |
| Manufacturer Street | 13705 SHORELINE COURT E. |
| Manufacturer City | EARTH CITY MO 63045 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YOUNG DENTAL STANDARD POINTED PROPHY BRUSH - 090201 |
| Generic Name | STANDARD POINTED PROPHY BRUSH |
| Product Code | EHK |
| Date Received | 2016-05-09 |
| Model Number | 090201 |
| Catalog Number | 090201 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG DENTAL MANUFACTURING CO 1, LLC |
| Manufacturer Address | 13705 SHORELINE COURT E. EARTH CITY MO 63045 US 63045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-09 |