MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for IVORY CLAMP 50057536 manufactured by Heraeus Kulzer, Llc.
[31084470]
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. Usage beyond the stated use life of one year and distorting the clamp during usage causing breakage of the clamp. The directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the user used the clamp beyond the stated use life and in a manner that is contraindicated. 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. " dfu indicate "attach a floss safety line to bow or clamp jaws.... And tie safety line to the frame. "
Patient Sequence No: 1, Text Type: N, H10
[31084471]
Dds emailed concern describing incident involving a (b)(6) female. Rubber dam clamp broke while being removed from patient's mouth. When the clamp split in half, part was ejected out of the patients mouth and into her lap and the other half lodged in her oral-pharynx against her tonsils. Upon sitting the patient upright she was able to cough the fragment of the clamp out of her mouth. Both portions of the clamp were accounted for, sterilized, and sent in for evaluation. Luckily the patient was only scared, no other harm came to her. Upon speaking with the dental assistant, the clamp was only partially ligatured and the dds was using hu-friedy forceps.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2015-00032 |
| MDR Report Key | 5210705 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-14 |
| Date of Event | 2015-10-09 |
| Date Mfgr Received | 2015-10-14 |
| Device Manufacturer Date | 1995-05-01 |
| Date Added to Maude | 2015-11-09 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 466142517 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 466142517 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IVORY CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2015-11-09 |
| Returned To Mfg | 2015-11-05 |
| Catalog Number | 50057536 |
| Lot Number | R5 |
| Device Expiration Date | 2000-05-01 |
| 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 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-09 |