MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for UMBILI-CLAMP CLW-1005-A01 manufactured by Divergent Medical Technologies, Inc..
[68997877]
Patient Sequence No: 1, Text Type: N, H10
[68997878]
Patient presented to mb with umbilical cord actively bleeding. Appeared as if the tot guard was causing the umbilical cord to "shred" causing the bleeding.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 6375967 |
MDR Report Key | 6375967 |
Date Received | 2017-03-03 |
Date of Report | 2017-02-14 |
Date of Event | 2017-02-05 |
Report Date | 2017-02-14 |
Date Reported to FDA | 2017-02-14 |
Date Reported to Mfgr | 2017-02-14 |
Date Added to Maude | 2017-03-03 |
Event Key | 0 |
Report Source Code | User Facility report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | UMBILI-CLAMP |
Generic Name | DEVICE, OCCLUSION, UMBILICAL |
Product Code | FOD |
Date Received | 2017-03-03 |
Model Number | CLW-1005-A01 |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | DIVERGENT MEDICAL TECHNOLOGIES, INC. |
Manufacturer Address | 5 FIR CT STE 1A OAKLAND NJ 07436 US 07436 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-03-03 |