MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-14 for MY CHILD POSITIVE IDENTIFICATION BASIC32-014 02-UTMTX01 manufactured by Mcroberts Security Technologies.
[62802799]
L&d reported that the mcroberts security system "my child positive identification kit" baby cord clamp id number and the mother's arm band numbers do not match. My baby/mother id system uses a umbilical cord clamp for the baby and an arm band for the mother. We/(b)(6) has three of these that the numbers do not match. The three have been identified prior to use and given to the rm department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066768 |
| MDR Report Key | 6185795 |
| Date Received | 2016-12-14 |
| Date of Report | 2016-12-14 |
| Date of Event | 2016-11-15 |
| Date Added to Maude | 2016-12-19 |
| 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 | MY CHILD POSITIVE IDENTIFICATION |
| Generic Name | MY CHILD POSITIVE IDENTIFICATION |
| Product Code | HFW |
| Date Received | 2016-12-14 |
| Model Number | BASIC32-014 |
| Catalog Number | 02-UTMTX01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCROBERTS SECURITY TECHNOLOGIES |
| Manufacturer Address | LAKEWOOD NJ 08701 US 08701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-14 |