MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-09-04 for ARTIC DENTURE TEETH manufactured by Heraeus Kulzer Dental Ltd..
[21730890]
Reference importer report number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[22089703]
(b)(4). Although we have not established that the device caused or contributed to the event, we're reporting it to be compliant with 21 cfr part 803 and out of an abundance of caution. The device was disposed of and not available for eval. Therefore cause cannot be determined. The complaint rate for breakage is 0. 00042 within the last year. No capa measures taken due to extremely low complaint rate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005431169-2013-00001 |
| MDR Report Key | 3414086 |
| Report Source | 00 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-06 |
| Date Facility Aware | 2013-08-06 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-10-17 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | UDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER DENTAL LTD. |
| Manufacturer Street | NO. 1585 GUMEI ROAD |
| Manufacturer City | SHANGHAI |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTIC DENTURE TEETH |
| Generic Name | ELM DENTURE, PLASTIC TEETH |
| Product Code | ELM |
| Date Received | 2013-09-04 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER DENTAL LTD. |
| Manufacturer Address | NO. 1585 GUMEI ROAD SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-04 |