MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-05-20 for IVORY CLAMP 50057310 manufactured by Heraeus Kulzer, Llc.
[45596054]
Narratives: 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 clamp had been severely torqued and hyperextended, leading to metal fatigue.
Patient Sequence No: 1, Text Type: N, H10
[45596055]
This complaint is from (b)(6). Dealer returned broken clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2016-00015 |
| MDR Report Key | 5669378 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-05-20 |
| Date of Report | 2016-04-29 |
| Date Mfgr Received | 2016-04-29 |
| Device Manufacturer Date | 2013-09-28 |
| Date Added to Maude | 2016-05-20 |
| 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 | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2016-05-20 |
| Returned To Mfg | 2016-05-05 |
| Catalog Number | 50057310 |
| Lot Number | A3 |
| Device Expiration Date | 2018-09-28 |
| 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 | 2016-05-20 |