MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-05-03 for IVORY CLAMP 500057843 manufactured by Heraeus Kulzer, Llc.
[74367512]
Clamp evaluation showed evidence of hyperextension. Shelf life for ivory clamps are 5 years, with the usage life being 1 year. This clamp has exceeded both. Despite multiple attempts to gather additional information from the reporting distributor, heraeus kulzer has not been provided with any specific information or events surrounding the breakage.
Patient Sequence No: 1, Text Type: N, H10
[74367513]
Dealer contacted heraeus kulzer and stated: "we received a broken clamp back. " there has been no additional information provided to heraeus kulzer in regards to this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2017-00012 |
| MDR Report Key | 6541588 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-05-03 |
| Date of Report | 2017-05-03 |
| Date Mfgr Received | 2017-04-07 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2017-05-03 |
| 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 | MRS. AMBER BROWN |
| Manufacturer Street | 4315 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer G1 | HERAEUS KULZER, LLC |
| Manufacturer Street | 4315 LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IVORY CLAMP |
| Generic Name | RUBBER DAM CLAMP |
| Product Code | EEF |
| Date Received | 2017-05-03 |
| Returned To Mfg | 2017-04-12 |
| Catalog Number | 500057843 |
| Lot Number | I0 |
| Device Expiration Date | 2015-02-15 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HERAEUS KULZER, LLC |
| Manufacturer Address | 4315 LAFAYETTE BLVD. SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-03 |