MAUDE Adverse Event Report: MEDLINE INDUSTRIES INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Catalog Number MDS138007

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Event Description

Multiple nurses report that product has inability to "pop" - break inner fluid bag to activate heat source.Purchasing notified.No injuries reported.Numerous product packaging being thrown away from inability to use.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MEDLINE INDUSTRIES; three lakes drive; northfield IL 60093
• MDR Report Key: 6519245
• MDR Text Key: 73616118
• Report Number: 6519245
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2017,04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS138007
• Device Lot Number: CN16308B1
• Other Device ID Number: 10080196719655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1