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

Catalog Number 41289

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

The below hot pack was found in milford.Ca self-tested before giving to the patient and reports it gets up to 176 degrees.It was extremely hot, and she felts her hands burning while holding it.It was too hot and she needed to let go.Too hot even wrapped with a towel.Manufacturer response for hot pack, (brand not provided) (per site reporter) just made a recommendation to use a different hot pack.

• 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: 15619225
• MDR Text Key: 301903721
• Report Number: 15619225
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 41289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1