MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-09-17 for VENUS SUPRA 66039110 manufactured by Heraeus Kulzer Gmbh.
[17156973]
Dealer rep e-mailed in the following: dr (b)(6) is using the supra polishing points and had one break on his first use the other day. I have the broken one if you need it. Spoke to the dentist. The polisher was a small grey flame. It broke on first use. He said he just touched the tooth and had not applied pressure when it split in half. He said no one was injured. He said that he has used the polisher for 2 years and has never had a problem with them. Ref. Mfr # 3005665377-2013-00001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2013-00136 |
| MDR Report Key | 3368374 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-08-22 |
| Date of Event | 2013-08-08 |
| Date Facility Aware | 2013-08-22 |
| Date Added to Maude | 2013-09-26 |
| 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 SUPRA |
| Generic Name | EHJ-ABRASIVE DISK |
| Product Code | EHJ |
| Date Received | 2013-09-17 |
| Returned To Mfg | 2013-09-13 |
| Catalog Number | 66039110 |
| Lot Number | 232529 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| 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 | 2013-09-17 |