MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-02-07 for IVORY CLAMP 12A 50057348 manufactured by Heraeus Kulzer Llc.
[4069282]
A dealer rep. Reported that he picked up a broken clamp from a dental office. He had no further information other than the doctor was unhappy this broke. (b)(6) 2014, spoke to office staff member. She said that they had the clamp about 6 months. She said they only use it about once a week so it was probably used about 24 times. She said that the clamp broke while it was being placed on the bicuspid. She did not remember what day or the patient. She said that there were no injuries; however, it was very upsetting when it broke. She said that it broke along the bow and they were able to retrieve both pieces. She said that they autoclave in a m11 machine on bagged setting. She mentioned that they had switched due to a number of (b)(4) clamps breaking along the wing.
Patient Sequence No: 1, Text Type: D, B5
[11662212]
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 device was found to have received multiple damage points and an excessive damage area on the top side of the jaw and bow, by a dental grinding tool. Device breakage is addressed in the directions, "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 warn, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the dentist said that no one was injured during the incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00010 |
| MDR Report Key | 3612128 |
| Report Source | 05,08 |
| Date Received | 2014-02-07 |
| Date of Report | 2014-01-08 |
| Date Mfgr Received | 2014-01-08 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2014-04-30 |
| 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 | 300HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2014-02-07 |
| Returned To Mfg | 2014-01-22 |
| 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 | 2014-02-07 |