MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2014-04-11 for IVORY CLAMP 50057348 manufactured by Heraeus Kulzer, Llc.
[4221829]
(b)(6) 2014 received forwarded email from a (b)(6) dealer with the following information within it: a dentist bought a clamp 12a on (b)(6) 2012. If you look invoice copy. It's broken in 2 parts. Request that the hk rep return the clamp for evaluation and informed that the clamp was out of warranty. Hk rep has tried to retrieve the clamp from the dealer, but it has not been available.
Patient Sequence No: 1, Text Type: D, B5
[11737423]
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 directions for use states, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " 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 clamp usage exceeded the use life of one year which is stated as the use life in the directions for use. Not returned/no lot info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2014-00019 |
| MDR Report Key | 3741239 |
| Report Source | 01,05,07,08 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-12 |
| Date Mfgr Received | 2014-03-12 |
| Date Added to Maude | 2014-06-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. AUDI BOGUCKI |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46617 |
| Manufacturer Country | US |
| Manufacturer Postal | 46617 |
| Manufacturer Phone | 5742995409 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46617 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46617 |
| 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 | 2014-04-11 |
| Catalog Number | 50057348 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46617 US 46617 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-11 |