MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-18 for UMBIL-KIT MOTHER/BABY POSITIVE IDENTIFICATION SYSTEM manufactured by Divergent Medical Technologies, Llc.
[106057261]
Cord clamp slipped off and a portion of the cord remained outside of the clamp. Nurse noticed cord was slightly bleeding. Diagnosis or reason for use: vaginal delivery, clamp umbilical cord. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076548 |
| MDR Report Key | 7442601 |
| Date Received | 2018-04-18 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-04-12 |
| 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 | UMBIL-KIT MOTHER/BABY POSITIVE IDENTIFICATION SYSTEM |
| Generic Name | IDENTIFICATION CORDCLAMP |
| Product Code | FOD |
| Date Received | 2018-04-18 |
| Lot Number | 11893 |
| ID Number | 11893 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |