MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-05 for MYCHILD INFANT SECURITY SYSTEM manufactured by Mcroberts Security Technologies.
[110063758]
Patient Sequence No: 1, Text Type: N, H10
[110063759]
The device is failing to control the elevators, as it is intended to do. Manufacturer response for infant security, my child (per site reporter): they sent contractors with no training, who are not competent to fix it. They don't have their own service staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7569001 |
| MDR Report Key | 7569001 |
| Date Received | 2018-06-05 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-04-01 |
| Report Date | 2018-05-29 |
| Date Reported to FDA | 2018-05-29 |
| Date Reported to Mfgr | 2018-05-29 |
| Date Added to Maude | 2018-06-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | MYCHILD INFANT SECURITY SYSTEM |
| Generic Name | CLAMP, UMBILICAL |
| Product Code | HFW |
| Date Received | 2018-06-05 |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCROBERTS SECURITY TECHNOLOGIES |
| Manufacturer Address | 46 THROCKMORTON STREET FREEHOLD NJ 07728 US 07728 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-05 |