MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-05 for VENUS DIAMOND FLOW BXL 660403654 manufactured by Heraeus Kulzer Gmbh.
[3969167]
This is the second of two reports for one office using two different devices. A dentist placed anterior and posterior fillings and they all came out a few weeks after placement. She used ibound te and venus diamond flow bxl. She etched the teeth with h2po 35% for 1 min, rinsed, lightly dried to leave slightly moist. She applied the bonding agent, and immediately air dried with short gentle air blast, and then cured for 20 seconds. Discussed allowing 15 seconds of dwell time and checking for uniform glossiness. The lot number of the venus diamond flow is an expired lot number. She placed these fillings in october after it had expired. Discussed that efficacy is not guaranteed after the expiry date. She had to get back to a pt so she had to get off the phone. Please refer mfr report # 9610902-2013-00117.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00168 |
| MDR Report Key | 3520741 |
| Date Received | 2013-12-05 |
| Date of Report | 2013-11-06 |
| Date Facility Aware | 2013-11-06 |
| Date Added to Maude | 2013-12-17 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal | 466142517 |
| Manufacturer G1 | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENUS DIAMOND FLOW |
| Generic Name | EBC SEALANT, PIT AND FISSURE, AND CONDI |
| Product Code | EBC |
| Date Received | 2013-12-05 |
| Model Number | BXL |
| Catalog Number | 660403654 |
| Lot Number | 010022 |
| Device Expiration Date | 2013-09-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 26 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | WEHRHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-05 |