MAUDE Adverse Event Report: STANLEY STANLEY KISSES TAGS

Device Problems Failure To Adhere Or Bond (1031); Premature Discharge of Battery (1057); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 04/15/2016

Event Type  malfunction  

Event Description

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.

• Brand Name: STANLEY KISSES TAGS
• Type of Device: STANLEY KISSES TAGS
• Manufacturer (Section D): STANLEY; ottawa, ontario K2K3A 3; CA K2K3A3
• MDR Report Key: 5630051
• MDR Text Key: 44590394
• Report Number: MW5062073
• Device Sequence Number: 1
• Product Code: ILQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other