MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-12 for IVORY CLAMP 50057528 manufactured by Heraeus Kulzer, Llc.
[45309855]
This malfunction is reportable as (b)(4) 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. Then malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. Same product with different lots were tested in a functional test. Visual inspection of actual device was evaluated.
Patient Sequence No: 1, Text Type: N, H10
[45309856]
(b)(6) dealer notified that office is alleging clamp broke first time using.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00014 |
| MDR Report Key | 5650322 |
| Date Received | 2016-05-12 |
| Date of Report | 2016-04-12 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-04-12 |
| Device Manufacturer Date | 2015-01-28 |
| Date Added to Maude | 2016-05-12 |
| 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 | MRS. AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995411 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 4315 LAFAYETTE BLVD. |
| 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 | 2016-05-12 |
| Returned To Mfg | 2016-04-29 |
| Catalog Number | 50057528 |
| Lot Number | J5 |
| 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 | 4315 LAFAYETTE BLVD. SOUTH BEND IN 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-12 |