MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-01-03 for IVORY CLAMP 12A 50057348 manufactured by Heraeus Kulzer Llc.
[3983318]
Received email from dealer that they received a clamp that broke on first use. Spoke to at the dental assistant at the office. She said that this clamp was new. She said that the dentist was working on the patient and it snapped. She said that no one was injured. She did not remember the patient or what day it happened on. She said the dentist might. She took a message with contact information and said she would see if he had anything to add. Called back later and left a message for the dentist to call back. No response to date.
Patient Sequence No: 1, Text Type: D, B5
[11407793]
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 - the clamp has signs of erosion even though the complaint is that the clamp was new and only used once. The clamp was therefore exposed to excessive heat and acids to cause the damage. The directions for use states, "inspect and sterilize clamp before each use. For optimum use, use a general-purpose cleaner prior to sterilization. Do not heat clamp above 350? F/177? C. " 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 conclusion - the directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the directions contain adequate warning and instructions. The dentist said that no one was injured during the incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00002 |
| MDR Report Key | 3551144 |
| Report Source | 05,08 |
| Date Received | 2014-01-03 |
| Date of Report | 2013-12-12 |
| Date Mfgr Received | 2013-12-12 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-04-07 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | EEF CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2014-01-03 |
| Returned To Mfg | 2013-12-20 |
| Model Number | 12A |
| Catalog Number | 50057348 |
| Lot Number | I3 |
| Device Expiration Date | 2018-02-28 |
| 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 | 2014-01-03 |