MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for UMBILI-CLAMP CLW-1004-A01 manufactured by Divergent Medical Technolgies, Llc.
[90780185]
Patient Sequence No: 1, Text Type: N, H10
[90780186]
Umbilical cord infection. Manufacturer response for umbilical cord clamp, umbili-clamp (per site reporter). Awaiting response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6993366 |
| MDR Report Key | 6993366 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-27 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-11-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 2017-11-01 |
| Catalog Number | CLW-1004-A01 |
| Lot Number | 20170510 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERGENT MEDICAL TECHNOLGIES, LLC |
| Manufacturer Address | 5 FIR CT STE 1A OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-01 |