MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-12-19 for IVORY CLAMP W5 50057526 manufactured by Heraeus Kulzer Llc.
[19967965]
(b)(6) dealer notified us via e-mail: the following complaint has arrived in (b)(6) already but has not yet been forwarded to you. The customer returned an ivory clamp ss w 5 s/n: (b)(4) with the following comment: the clamp broke after having been used a few times only.
Patient Sequence No: 1, Text Type: D, B5
[20305740]
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. Results and conclusion: device breakage is addressed in the directors for use. The directions state, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. 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. " conclusion: the dealer has not returned the clamp. The lot number given is not a current lot number. The last time this lot number was used was (b)(6) 1994. The clamp would be 19 years old and well out of use life of one year.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2013-00172 |
| MDR Report Key | 3635064 |
| Report Source | 01,08 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-27 |
| Date Mfgr Received | 2013-11-27 |
| Date Added to Maude | 2014-03-31 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDI BOGUCKI, RDH |
| Manufacturer Street | 300 HERAEUS WAY |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 5742995409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | EEF CLAMP, RUBBER DAM |
| Product Code | EEF |
| Date Received | 2013-12-19 |
| Model Number | W5 |
| Catalog Number | 50057526 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER LLC |
| Manufacturer Address | 300 HERAEUS WAY SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-19 |