MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-12 for VENUS SUPRA FLAME manufactured by Heraeus Kulzer Gmbh.
[15819460]
A customer who has used the polisher for several years complained that it broke on first use. The lot number is not available as the polisher was stored away from its packaging. Reference mfr report 3005665377-2013-00006.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00158 |
| MDR Report Key | 3666830 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-14 |
| Date Added to Maude | 2014-03-10 |
| 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 | 0 |
| 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 SUPRA |
| Generic Name | EHJ-ABRASIVE DISK |
| Product Code | EHJ |
| Date Received | 2013-11-12 |
| Model Number | FLAME |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | HANAU D-63450 GM D-63450 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-12 |