MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-09-12 for IVORY RUBBER DAM CLAMP 50057310 manufactured by Heraeus Kulzer.
[16310546]
This took place in (b)(6). (b)(6). She has a #2 ivory clamp, lot a1 that was returned by a doctor because it is broken. She said no further information is available. Comments: this incident occurred in (b)(6). This malfunction is reportable as sec. 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
[16386022]
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. Conclusion - device breakage is addressed in the directions for use. The directions state, "do not place clamp in mouth until the rubber dam has been properly placed. Clamp could become a choking or safety hazard if dropped or broken in the mouth without proper use of the rubber dam at all times.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00065 |
| MDR Report Key | 4086093 |
| Report Source | 01,08 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-08-27 |
| Date Mfgr Received | 2014-08-27 |
| Device Manufacturer Date | 2011-09-12 |
| Date Added to Maude | 2014-09-25 |
| 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 | 3 |
| 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 |
| 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 RUBBER DAM CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2014-09-12 |
| Returned To Mfg | 2014-09-02 |
| Catalog Number | 50057310 |
| Lot Number | A1 |
| Device Expiration Date | 2016-09-12 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |