MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-08-10 for IVORY RUBBER DAM CLAMP 12A 50057348 manufactured by Kulzer, Llc.
[83134629]
This complaint originated in (b)(6), and was reported to kulzer (b)(4). It was recorded by kulzer (b)(4) as safety-standard instead of safety-critical. Kulzer (b)(4) was made aware (b)(4) 2017. There was no hazard for user, patient or third party. 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: N, H10
[83134630]
This complaint came from a customer in (b)(6). Clamp broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2017-00019 |
| MDR Report Key | 6786300 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-08-10 |
| Date of Report | 2016-12-21 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2017-08-10 |
| 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. RITA ROGERS |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | KULZER, LLC |
| Manufacturer Street | 4315 SOUTH LAFAYETTE BLVD. |
| Manufacturer City | SOUTH BEND 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY RUBBER DAM CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2017-08-10 |
| Model Number | 12A |
| Catalog Number | 50057348 |
| Lot Number | M5 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, LLC |
| Manufacturer Address | 4315 SOUTH LAFAYETTE BLVD. SOUTH BEND 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-10 |