MAUDE Adverse Event Report: HMS (HOSPITAL MARKETING SERVICES) INSTANT WARM PACK DISPOSABLE

Lot Number 9169-1

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2014

Event Type  malfunction  

Event Description

While patient care technician was attempting to activate warm pack, the pack opened up and spilled on the pct's hand.No patient affected.Pct did not require further follow up or treatment.

• Brand Name: INSTANT WARM PACK DISPOSABLE
• Type of Device: WARM PACK
• Manufacturer (Section D): HMS (HOSPITAL MARKETING SERVICES); 162 great hill rd.; naugatuck CT 06770
• MDR Report Key: 4172989
• MDR Text Key: 15124418
• Report Number: 4172989
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 9169-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1