MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-06-30 for IVORY CLAMP SS 2 50057310 manufactured by Heraeus Kulzer Llc.
[4544668]
This clamp breakage occurred in (b)(6). (b)(6) from sigma dental (b)(6) emailed the following: customer returned 2 ivory clamps ss 2 due to the fact that they are broken. The corresponding serial number is (b)(4). Both clamps have been purchased by the customer on (b)(6) 2014. No incident date(s) were provided. The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[12026040]
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. Results: device problems caused by the separation of a component, object, or material into two or more pieces including shear. Conclusion: actual device has not yet been returned to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00053 |
| MDR Report Key | 3901575 |
| Report Source | 01,08 |
| Date Received | 2014-06-30 |
| Date of Report | 2014-06-02 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-07-21 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MARC HENN |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995444 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2014-06-30 |
| Model Number | SS 2 |
| Catalog Number | 50057310 |
| Device Expiration Date | 2016-09-12 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-30 |