MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-01 for DRI-CLAVE VK4 500360208 manufactured by Heraeus Kulzer, Llc.
[5757039]
Call from patient, who identified herself as (b)(6) call was from unknown number. Patient stated she had been given our information by her dds. Patient stated the last two times she had her teeth cleaned, upon putting her partial back into her mouth, she had nearly immediate intense pain on her palate. Patient stated she suffered for three weeks with sore palate symptoms and was supplied cream to help with the healing. Dds let her read the gallon container containing the product in question, which is dri-clave vk4, and supplied her with msds. Patient states she is allergic to peg (phenyl ethyl glycol)and wanted to know if that was contained in our product. I read the label to her as well, and noted the product needs to be neutralized with sodium bicarb and water. There is no indication that this step is being taken. Phoned the dental office to inform them of proper procedures, without disclosing patient information. Informed patient that i could not give her medical advice nor determine her potential reaction to our products, but i did recommend that she avoid tartar and stain remover in the future. She may follow through with additional allergy testing. This is a serious injury (as defined in 21 cfr section 803. 3) and requires intervention to prevent potential permanent harm to a body structure. This incident will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[13045817]
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. Tissue irritation is addressed in the directions for use. The cautionary label states,"corrosive liquid. Acidic detergent mixture contains sulfamic acid, alkyl dimethyl benzyl ammonium chloride and isopropyl alcohol. May cause 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. If swallowed, drink large quantities of water. Call a physician immediately. " also, under dfu: "dentures, bridges, orthodontics appliances and other acrylic items should be neutralized in a solution of 1 teaspoon bicarbonate of soda diluted in a cup of water. No failure of the medical device was detected. Tissue irritation is a known inherent risks of using this medical device, and user error in failing to adequately neutralize product contributed to this event. Product not returned by dental practice.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2015-00014 |
| MDR Report Key | 4648177 |
| Report Source | 04 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-23 |
| Date Mfgr Received | 2015-03-23 |
| Date Added to Maude | 2015-04-01 |
| 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 | 0 |
| Event Location | 0 |
| 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 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DRI-CLAVE VK4 |
| Generic Name | CLEANER, ULTRASONIC, MEDICAL INSTRUMENT |
| Product Code | FLG |
| Date Received | 2015-04-01 |
| Catalog Number | 500360208 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-01 |