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

Catalog Number MPR-41289

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2022

Event Type  malfunction  

Event Description

Medpride instant hot pack is extremely hot after activating.It is difficult to manage with your bare hands.Even when wrapped in a pillow case as instructed by their guidelines it is still too hot.Health care provider tested it by placing it over sweater sleeve and it left their arm red after only a few minutes.The pack states that it heats up to 176 degrees fahrenheit.This was a substitution product for us.Our normal product, cardinal health hot packs reaches 100-110 degrees fahrenheit with a max of 111.8 degrees fahrenheit.Concerned the medpride product could burn a staff member or patient ¿ especially a patient with sensory impairment due to medical status, medications, etc.

Event Description

Medpride instant hot pack is extremely hot after activating.It is difficult to manage with your bare hands.Even when wrapped in a pillow case as instructed by their guidelines it is still too hot.Health care provider tested it by placing it over sweater sleeve and it left their arm red after only a few minutes.The pack states that it heats up to 176 degrees fahrenheit.This was a substitution product for us.Our normal hot/cold therapy pack product reaches 100-110 degrees fahrenheit with a max of 111.8 degrees fahrenheit.Concerned the medpride product could burn a staff member or patient ¿ especially a patient with sensory impairment due to medical status, medications, etc.

• 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: 15629306
• MDR Text Key: 301998973
• Report Number: 15629306
• 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,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MPR-41289
• Device Lot Number: 205851
• 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: 09/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1