MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

Hot pack leaked onto patients t-shirt and through to open skin.Patient had open wound from recent mole removal.Skin and surrounding area cleaned by rn, clothing changed and patient assessed.Per patient, skin stung.Green intern notified.Hot pack brand medline - instant hot pack.It was used as directed.Found small hole in corner.

• Brand Name: MEDLINE INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9075676
• MDR Text Key: 158812189
• Report Number: 9075676
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5840 DA