MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for HUGS INFANT PROTECTION * 806A2001 manufactured by Stanley Security Solutions, Inc.
[4831831]
Per nurse coordinator on pediatrics: 1. When you put the strap through the hugs tag, the strap curls and pulls apart. 2. An rn pulled the strap out of a hugs tag and the alarm should have gone off and it didn't. 3. There were multiple patients that this happened to. Also there were some from devices in this box of straps that worked fine. The unit has been using another box of straps with the same number that is stamped on the end of the box for two days and have had no isses. This issues have happened with multiple staff members. Customer service contacted and said i could not send it back. ====================== manufacturer response for infant security strap for the hugs tags, hugs infant protection (per site reporter)======================i had to leave a message with qa.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4095174 |
| MDR Report Key | 4095174 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-09-15 |
| Report Date | 2014-09-16 |
| Date Reported to FDA | 2014-09-16 |
| Date Reported to Mfgr | 2014-09-17 |
| Date Added to Maude | 2014-09-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUGS INFANT PROTECTION |
| Generic Name | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION O |
| Product Code | ILQ |
| Date Received | 2014-09-16 |
| Model Number | * |
| Catalog Number | 806A2001 |
| Lot Number | 400082 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY SECURITY SOLUTIONS, INC |
| Manufacturer Address | 4600 VINE ST LINCOLN NE 68503 US 68503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-16 |