MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-06-20 for IVORY CLAMP SS 12A 50057348 manufactured by Heraeus Kulzer Llc.
[2763604]
On (b)(6) 2012, henry schein rep sent (b)(4). The description on the form was, "clamp broke in pt's mouth with no injury. " on (b)(4) 2012, i spoke to the assistant. I asked when this occurred. She said it was on friday ((b)(6) 2012). She said the pt was (b)(6) male. They were removing the clamp from a lower molar, she did not remember which one, and it broke. She said that the rubber dam was in place and the clamp pieces fell to the floor. I asked her if she knew how many uses were on the clamp. She said she was not sure, but that the clamp was fairly new. I asked if anyone was injured. She said that no one was injured.
Patient Sequence No: 1, Text Type: D, B5
[10061293]
Due to the clamp breakage allegedly occurring on fairly new the clamp the malfunction will be reported to maintain compliance with 21 cfr 803 and out of an abundance of caution. Conclusion: device breakage is addressed in the directions for use. The directions state, "caution: modification, overextending, bending or extended use of the clamp may cause breakage. " the dentist has stated that no one was injured during the incidences.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925223-2012-00045 |
| MDR Report Key | 2629817 |
| Report Source | 05,08 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-05-23 |
| Date Mfgr Received | 2012-05-25 |
| Date Added to Maude | 2012-10-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | AUDRA 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 | CLAMP, RUBBER DAM |
| Product Code | EJG |
| Date Received | 2012-06-20 |
| Model Number | SS 12A |
| Catalog Number | 50057348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2012-06-20 |