MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-27 for UMBILICAL CORD CLAMP 6833 manufactured by Deroyal Industries.
[14928825]
Clamp not staying closed on umbilical cord allowing bleeding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2011-00007 |
| MDR Report Key | 2449571 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-27 |
| Date of Report | 2011-02-24 |
| Date of Event | 2011-02-01 |
| Date Facility Aware | 2011-02-01 |
| Report Date | 2011-02-24 |
| Date Added to Maude | 2012-07-26 |
| 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 Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES |
| Manufacturer Street | 1703 HWY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2011-12-27 |
| Returned To Mfg | 2011-03-08 |
| Catalog Number | 6833 |
| Lot Number | 24946343 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-27 |