MAUDE Adverse Event Report: SHIELD LINE LLC MEDPRIDE; PACK, HOT OR COLD, DISPOSABLE

Device Problem Break (1069)

Patient Problems Emotional Changes (1831); Burning Sensation (2146); Chemical Exposure (2570)

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Another hot pack exploded onto a nurse this morning.She reported that the substance felt "hot" and she felt panicked when her skin started to feel like it was burning and i sent her immediately to occupational health.Her skin appeared to be fine when she left but she was visibly shaken.When asked if she had to "force" the pack to activate she said "absolutely not".Upon her initial squeeze, per the attached instructions, it exploded on her neck, forearm, hands, scrubs (both top and bottom), jacket, and shoes.Fortunately, she was nowhere near a patient and no one else was injured.A safe care event will be entered.

• Brand Name: MEDPRIDE
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): SHIELD LINE LLC; 1 university plaza; suite 514; hackensack NJ 07601
• MDR Report Key: 17182780
• MDR Text Key: 317674205
• Report Number: 17182780
• 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: 06/08/2023

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: 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: 06/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1