MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-02 for POSITIVE ID INFANT BASIC 31-012 manufactured by Mcroberts Security Technologies.
[39776218]
Nurse was filling out necessary information and noticed the numbering system in the baby bracelet packet did not match. Second bag was obtained and found the same problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5060742 |
| MDR Report Key | 5479563 |
| Date Received | 2016-03-02 |
| Date of Report | 2016-01-14 |
| Date of Event | 2016-01-12 |
| Date Added to Maude | 2016-03-04 |
| 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 | POSITIVE ID INFANT |
| Generic Name | POSITIVE ID INFANT |
| Product Code | LDQ |
| Date Received | 2016-03-02 |
| Returned To Mfg | 2016-01-14 |
| Model Number | BASIC 31-012 |
| Lot Number | 120415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCROBERTS SECURITY TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-02 |