MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for UMBILI-KIT MOTHER/BABY POSITIVE IDENTIFICATION SYSTEM manufactured by Divergent Medical Technologies, Llc.
[106060957]
Upon verification of bracelets and cord clamp, on admission to nursery unit, it was noted that infant was bleeding from cord. Pressure was applied to the umbilical stump to prevent infant from bleeding while rn reclamped cord with our sterile non labeled clamp. No further incident noted. Clamp was not fully attached to cord and opened. Dates of use: (b)(6) 2018. Diagnosis or reason for use: vaginal delivery, clamp umbilical cord.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076549 |
| MDR Report Key | 7442603 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-04-16 |
| Date Added to Maude | 2018-04-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UMBILI-KIT MOTHER/BABY POSITIVE IDENTIFICATION SYSTEM |
| Generic Name | CORDCLAMP KIT |
| Product Code | FOD |
| Date Received | 2018-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERGENT MEDICAL TECHNOLOGIES, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-04-18 |