MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-07-01 for DEROYAL 6833 manufactured by Deroyal Industries, Inc..
[3652536]
The cord is tearing away and/or separating below the clamp, making the baby bleed. They have to apply silver nitrate, tie with cord tie, and take off the clamp.
Patient Sequence No: 1, Text Type: D, B5
[10993885]
Describe event or problem: the cord is tearing away and / or separating below the clamp, making the baby bleed. They have to apply silver nitrate, tie with cord tie, and take off the clamp. (b)(4) the reported sample has not been returned to (b)(4) at this time. The investigation into the root cause is in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2013-00002 |
| MDR Report Key | 3216876 |
| Report Source | 06 |
| Date Received | 2013-07-01 |
| Date of Report | 2013-06-10 |
| Date of Event | 2013-05-31 |
| Date Facility Aware | 2013-05-31 |
| Report Date | 2013-06-10 |
| Date Reported to Mfgr | 2013-06-10 |
| Date Mfgr Received | 2013-06-10 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-07-11 |
| 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 LN. |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 700 MARTIN LUTHER KING JR. BLVD. |
| Manufacturer City | SANFORD FL 32771 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32771 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | FOD- DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2013-07-01 |
| Catalog Number | 6833 |
| Lot Number | 31805944 |
| Device Expiration Date | 2018-03-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | SANFORD FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-01 |