MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-28 for TOTGUARD 61-10007 manufactured by Guard Rfid Solutions Inc..
[3473486]
Tot guard umbilical tag in place with divergent cord clamp. Infant's umbilical cord detached prematurely from umbilicus due to the weight of the divergent cord clamp and tot guard tag. No bleeding noted at cord site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030764 |
| MDR Report Key | 3209246 |
| Date Received | 2013-06-28 |
| Date of Report | 2013-06-28 |
| Date of Event | 2013-06-22 |
| Date Added to Maude | 2013-07-09 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOTGUARD |
| Generic Name | INFANT SECURITY UMBILICAL TAG |
| Product Code | HFW |
| Date Received | 2013-06-28 |
| Catalog Number | 61-10007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUARD RFID SOLUTIONS INC. |
| Manufacturer Address | 766 CLIVEDEN PLACE UNIT 140 DELTA, BC V3M6C7 CA V3M 6C7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-28 |