MAUDE Adverse Event Report: ASP GLOBAL, LLC INSTANT WARM PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number 00823

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

As staff was preparing heat pack for use, the contents splattered out onto staff's hands and clothes.Fda safety report id# (b)(4).

• Brand Name: INSTANT WARM PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): ASP GLOBAL, LLC; 7800 third flag pkwy; austell GA 30168
• MDR Report Key: 13170024
• MDR Text Key: 283338107
• Report Number: MW5106472
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/03/2022

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 Expiration Date: 08/23/2022
• Device Lot Number: 00823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female