MAUDE Adverse Event Report: ASP MEDICAL; PACK, HOT OR COLD, DISPOSABLE

Device Problem Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

Staff was squeezing a single-use asp medical instant warm pack to rupture the inner fluid pouch.The outer part of the heating pouch broke and the inside material exploded onto the patient's bed and it had gotten onto a small part of patient's arm.Patient rinsed arm immediately and the room was cleaned and linens changed.Patient does not complain of any signs/symptoms of injury.Medical center was able to remove all the heat packs from their current supply.Supply chain was to notify vendor- unknown if this was done.

• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): ASP MEDICAL; 15815 sw 11th court rd; ocala FL 34473
• MDR Report Key: 14134872
• MDR Text Key: 289437885
• Report Number: 14134872
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2022
• Date Report to Manufacturer: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1