MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-03-25 for IVORY CLAMP 50057312 manufactured by Heraeus Kulzer, Llc.
[5617788]
Email from (b)(4) rep, with few details; date: (b)(6) 2015 at 13:57:45 cst. To: "(b)(6). " subject: kulzer-request for return. Hi (b)(4), please find attached s/s with 5 items we want to return. Can i please get rma# since tomorrow is month end? (b)(4). No further details were provided with regard to patient involvement, date, location or details of malfunction. Broken clamp is the allegation. This malfunction is reportable as sec. 803. 50 states: if you are a manufacturer, you must report to us no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[13115880]
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 code 22- 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 device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2015-00012 |
| MDR Report Key | 4630114 |
| Report Source | 01,08 |
| Date Received | 2015-03-25 |
| Date of Report | 2015-02-26 |
| Date Mfgr Received | 2015-02-28 |
| Date Added to Maude | 2015-04-27 |
| 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 | 0 |
| Event Location | 0 |
| 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 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| 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 | 2015-03-25 |
| Catalog Number | 50057312 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-25 |