MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-10 for VENUS DIAMOND FLOW SYR A1 66040354 manufactured by Heraeus Kulzer Gmbh.
[3863486]
This is the first of four reports for one office. Spoke to dental assistant. She said that they noticed air bubbles while extruding. She said that about four pts have returned due to sensitivity and they replaced the restorations. Two for the shade a1 and two for shade a2. She said that the sensitivity resolved and they are doing fine. She said that they cure the vdf for 20 seconds minimum with an led curing light. Please refer mfr report # 9610902-2013-00094.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00131 |
| MDR Report Key | 3353264 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-08-14 |
| Date Facility Aware | 2013-08-14 |
| Date Added to Maude | 2013-09-18 |
| 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 SYR |
| Generic Name | EBC SEALANT, PIT AND FISSURE, AND CONDI |
| Product Code | EBC |
| Date Received | 2013-09-10 |
| Returned To Mfg | 2013-09-09 |
| Model Number | A1 |
| Catalog Number | 66040354 |
| Lot Number | 010105 |
| Device Expiration Date | 2016-09-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| 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 | 2013-09-10 |