MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for TARTAR AND STAIN REMOVER 50036330 manufactured by Heraeus Kulzer, Llc.
[37424940]
Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. Narrative for codes: corrosive properties are addressed in the directions for use. The directions state,"contains sulfamic acid. Causes skin or eye irritation. Harmful if swallowed. In case of contact, flush eyes or skin with plenty of water. If irritation persists, seek medical attention. " no failure of the medical device was detected. Manufacturer's dfu for the flexible partial material recommends the use of their own gentle cleaners.
Patient Sequence No: 1, Text Type: N, H10
[37424941]
By way of patient: allegation of harm and complaints of painful soft tissue after flexible partial was placed in highly acidic tartar and stain remover.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00004 |
| MDR Report Key | 5408668 |
| Date Received | 2016-02-03 |
| Date of Report | 2016-01-13 |
| Date of Event | 2016-01-04 |
| Date Mfgr Received | 2016-01-13 |
| Device Manufacturer Date | 2015-01-04 |
| Date Added to Maude | 2016-02-03 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. RITA ROGERS |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 466142517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TARTAR AND STAIN REMOVER |
| Generic Name | CLEANER, ULTRASONIC, MEDICAL INSTRUMENT |
| Product Code | FLG |
| Date Received | 2016-02-03 |
| Catalog Number | 50036330 |
| Lot Number | 15010014 |
| Device Expiration Date | 2017-01-04 |
| Operator | DENTAL HYGIENIST |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-03 |