MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-03-06 for IVORY CLAMP 27N 50057730 manufactured by Heraeus Kulzer Llc.
[4194177]
Dealer emailed that they had received a complaint from a customer that a brand new clamp broke on the patient's tooth. Dealer sent the following information concerning the breakage via email: we have followed up with the client and obtained the following information: no injuries occurred. The client was unable to remember which tooth was treated and the breakage date. In regards to the dentist's details the sale of the clamp is via a 3rd party dental dealer based in here in sydney. Thus the dentist's details have not been noted.
Patient Sequence No: 1, Text Type: D, B5
[11708378]
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. Narrative for 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. Narrative for results and conclusions: the directions for use warns, caution: modification, over-extending, bending, or use exceeding one year may cause breakage. The return clamp was not brand new as claimed by the customer (see attached photos). The clamp appears to have been in use beyond one year and was used improperly. No one was injured during the incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00016 |
| MDR Report Key | 3662606 |
| Report Source | 01,08 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-06 |
| Date Mfgr Received | 2014-02-06 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2014-05-14 |
| 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 | MS. AUDI BOGUCKI |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND 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 | 2014-03-06 |
| Returned To Mfg | 2014-02-21 |
| Model Number | 27N |
| Catalog Number | 50057730 |
| Lot Number | C2 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-06 |