MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2014-03-04 for IVORY CLAMP 12 A 50057348 manufactured by Heraeus Kulzer Llc.
[4281773]
Dealer rep. Sent in a request for rma number for a broken clamp. Requested dental office information and return of clamp. Called the dental office and spoke to assistant. She said that the clamp snapped while they were in the middle of the procedure. She said that no one was injured as the patient and staff had their goggles on. She said it was very upsetting when it occurred. She did not remember exactly which patient it was as this happened in (b)(6) 2013. She said that they only just received the clamp as the clinic opened on (b)(6) 2013. She did remember that the patient was a juvenile and they were treating a primary molar.
Patient Sequence No: 1, Text Type: D, B5
[11692728]
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. " the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the dental assistant said that no one was injured during the incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00014 |
| MDR Report Key | 3657296 |
| Report Source | 01,05,08 |
| Date Received | 2014-03-04 |
| Date of Report | 2014-02-04 |
| Date Mfgr Received | 2014-02-04 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-05-13 |
| 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 |
| Reporter Occupation | DENTAL ASSISTANT |
| 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 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 | 2014-03-04 |
| Returned To Mfg | 2014-02-11 |
| Model Number | 12 A |
| Catalog Number | 50057348 |
| 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 | 2014-03-04 |