MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for IVORY RUBBER DAM FORCEPS 50057220 manufactured by Heraeus Kulzer, Llc.
[41726051]
This device was used for many years beyond its five-year shelf life. Due to the aforementioned fact that this was customer misuse, no further action is deemed necessary at this time. The investigation is closed. Capa measures are not proposed or initiated.
Patient Sequence No: 1, Text Type: N, H10
[41726052]
Package received by manufacturer containing letter and broken rubber dam forceps from dentist in (b)(6). Description is that forceps broke while in use. Forceps were found to be at least 25 years old, and expired by at least 20 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00011 |
| MDR Report Key | 5531956 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-18 |
| Date of Event | 2016-02-18 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 1991-01-01 |
| Date Added to Maude | 2016-03-29 |
| 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 | 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 RUBBER DAM FORCEPS |
| Generic Name | RUBBER DAM AND ACCESSORIES |
| Product Code | EEF |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2016-03-18 |
| Model Number | IVORY RUBBER DAM FORCEPS |
| Catalog Number | 50057220 |
| Device Expiration Date | 1996-01-01 |
| 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 | 300 HERAEUS WAY SOUTH BEND IN 466142517 US 466142517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |