MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-29 for IVORY CLAMP IVORY CLAMP SS 12A 50057348 manufactured by Heraeus Kulzer, Llc.
[5826754]
Dental assistant reports an ivory clamp ss 12a reg molar broke in a patient's mouth today. The clamp broke into two pieces and both pieces were caught by the rubber dam material. When asked, the da said they were using hu-friedy rubber dam forceps. I recommended in the future that they use only genuine ivory rubber dam forceps which are stamped "made in usa", as these forceps are the ones manufactured to specifications of the clamp extension. Other forceps may allow the prongs to open too far and hyper extend the wings of the clamp, potentially leading to fracture. Agreed to replace ivory clamp ss 12a reg molar.
Patient Sequence No: 1, Text Type: D, B5
[13323575]
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 rubber dam clamp has been thrown away by the dental staff.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1821514-2015-00018 |
| MDR Report Key | 4736161 |
| Report Source | 01,05 |
| Date Received | 2015-04-29 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-14 |
| Date Facility Aware | 2015-04-14 |
| Date Mfgr Received | 2015-04-14 |
| Device Manufacturer Date | 2013-02-28 |
| Date Added to Maude | 2015-06-01 |
| 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. RITA ROGERS |
| 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 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| 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 | CEK |
| Date Received | 2015-04-29 |
| Model Number | IVORY CLAMP SS 12A |
| Catalog Number | 50057348 |
| Lot Number | I3 |
| Device Expiration Date | 2015-02-28 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Age | 26 MO |
| 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 IN 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-29 |