MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-29 for STANLEY KISSES TAGS manufactured by Stanley.
[44590394]
Concern: kisses tags are not bonding with the hugs tags. This past year the company changed from a kiss tag (mothers) that had battery life for one year, to a tag with battery life for three months. Since then we have to replace tags every three months. The quality of bonding has dramatically decreased. Definitions: hugs tags are the tag on infants that alarm when baby gets close to entrance/exits. Kiss tag is the mother's tag that chimes/lullabies when bonded with their babies hug tag. Purpose is to give indications if wrong baby is given to wrong mother. Data: since (b)(6) there has been an increase in kisses tags not bonding with the hugs tags; 63 were reported by cccs. We have used this product for years with no issues. When the manufacturer changed the battery life, they do not work anymore. This lack of bonding of the two bracelets leads to an erosion of trust for both the customer and the staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062073 |
| MDR Report Key | 5630051 |
| Date Received | 2016-04-29 |
| Date of Report | 2016-04-23 |
| Date of Event | 2016-04-15 |
| Date Added to Maude | 2016-05-04 |
| 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 | STANLEY KISSES TAGS |
| Generic Name | STANLEY KISSES TAGS |
| Product Code | ILQ |
| Date Received | 2016-04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STANLEY |
| Manufacturer Address | OTTAWA, ONTARIO K2K3A3 CA K2K3A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-29 |