MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-03-11 for IVORY CLAMP 12A REGMOLAR 50057348 manufactured by Heraeus Kulzer, Llc.
[21175117]
This took place in (b)(6). To: (b)(4). Subject: complaint rubber dam clamp. Dear mr. (b)(4), i received a broken rubber dam clamp back#12a from a customer. Would you like me to send it back to you for some kind of investigation. Therefor i need an rma#, i think. Thank you. Regards (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[21372672]
Narrative for results - usage beyond the stated use life of one year and distorting the clamp during usage causing breakage of the clamp. Narrative for conclusion - 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. Analysis of returned broken clamp. Item evaluated: ivory clamp ss 12a reg molar lot no. : a3, manufacture date: 09/28/2013, receipt date: 02/24/2015, complaint: broken. Evaluation summary: only a fragment of the clamp was received for analysis. The clamp broke in the bow area, lower by the wing. The dfu states, "caution: modification, over-extending, bending, or use exceeding one year may cause breakage. " cause of breakage: the returned fragment was too small to evaluate. Conclusion: the complaint is not confirmed as a quality defect due to lack of information. 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
| Report Number | 1925223-2015-00010 |
| MDR Report Key | 4591047 |
| Report Source | 01,08 |
| Date Received | 2015-03-11 |
| Date of Report | 2015-02-18 |
| Date Mfgr Received | 2015-02-18 |
| Device Manufacturer Date | 2013-09-28 |
| Date Added to Maude | 2015-04-14 |
| 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 | 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 46614251 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 2517 |
| 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 | 2015-03-11 |
| Returned To Mfg | 2015-02-24 |
| Model Number | 12A REGMOLAR |
| Catalog Number | 50057348 |
| Lot Number | A3 |
| Device Expiration Date | 2018-09-28 |
| 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 46614251 US 46614 2517 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-11 |