MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-06-02 for IVORY RUBBER DAM CLAMP 50057568 manufactured by Kulzer, Llc.
[76528625]
Device is expected to be shipped back to our facility for evaluation from distributor. At this time it is evident based on the lot number stamp that is visible in the photograph provided by the distributor that the clamp has exceed it's shelf life of 5 years by 2 years, 2 months.
Patient Sequence No: 1, Text Type: N, H10
[76528626]
Clamp returned. Snapped while using.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1821514-2017-00013 |
| MDR Report Key | 6607649 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-06-02 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-05-01 |
| Date Facility Aware | 2017-05-04 |
| Report Date | 2017-06-02 |
| Date Reported to FDA | 2017-06-02 |
| Date Mfgr Received | 2017-05-04 |
| Date Added to Maude | 2017-06-02 |
| 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 Phone | 5742995411 |
| Manufacturer G1 | 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 RUBBER DAM CLAMP |
| Generic Name | RUBBER DAM CLAMP |
| Product Code | EEF |
| Date Received | 2017-06-02 |
| Returned To Mfg | 2017-06-22 |
| Catalog Number | 50057568 |
| Lot Number | V0 |
| Device Expiration Date | 2015-03-12 |
| Device Availability | R |
| Device Age | 17 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KULZER, LLC |
| Manufacturer Address | 4315 LAFAYETTE BLVD SOUTH BEND IN 46614 US 46614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-02 |