MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-05 for VENUS DIAMOND FLOW manufactured by Heraeus Kulzer Gmbh.
[18312037]
Please refer importer report # 1925223-2013-00168.
Patient Sequence No: 1, Text Type: D, B5
[18400952]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be complaint with 21 cfr part 803 and out of an abundance of caution. The dentist used the material after it expired which could have led to bond failure. Capa were not recommended as efficacy of material cannot be guaranteed after expiration and use is warned against in the directions for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610902-2013-00117 |
| MDR Report Key | 3520729 |
| Report Source | 05,07 |
| Date Received | 2013-12-05 |
| Date Added to Maude | 2013-12-17 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER GMBH & CO. KG |
| Manufacturer Street | PHILIPP-REIS-STRASSE 8/13 |
| Manufacturer City | WEHRHEIM |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| 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 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER GMBH |
| Manufacturer Address | WEHRHEIM GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-05 |