MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-15 for IVORY CALMP 12A 50057348 manufactured by Heraeus Kulzer, Llc.
[53038454]
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. Distorting the clamp during usage causing breakage of the clamp. 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 directions for use warns, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " the user used the clamp in a manner that is contraindicated by hyperextending the clamp.
Patient Sequence No: 1, Text Type: N, H10
[53038455]
Broken clamp returned by (b)(6) dealer, no details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00023 |
| MDR Report Key | 5875045 |
| Date Received | 2016-08-15 |
| Date of Report | 2016-07-27 |
| Date Mfgr Received | 2016-07-27 |
| Device Manufacturer Date | 2015-08-28 |
| Date Added to Maude | 2016-08-15 |
| 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 |
| 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 CALMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2016-08-15 |
| Returned To Mfg | 2016-08-10 |
| Model Number | 12A |
| Catalog Number | 50057348 |
| Lot Number | L5 |
| 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 | 2016-08-15 |