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

Catalog Number MDS139010

Device Problem Material Rupture (1546)

Patient Problem Irritation (1941)

Event Date 12/20/2018

Event Type  malfunction  

Event Description

While squeezing medline instant hotpack to activate, pack ruptured and sprayed contents all over patient, room and nurse.Contents got on patient's skin, including near her left eye.Patient stated she felt slight eye irritation.Skin cleansed immediately with soap and water.Eye irrigation done for 15 minutes with sterile saline.At time of discharge, patient had no complaints.No eye redness noted.Anatomical therapeutic chemical (atc) director and environmental services notified immediately.Material safety data sheet (msds) supplied to direct first aid efforts.Manufacturer response for instant hot pack, medline instant hot pack (per site reporter) contacted sales rep.

• Brand Name: MEDLINE INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 8349427
• MDR Text Key: 136461741
• Report Number: 8349427
• 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: 02/12/2019,01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS139010
• Device Lot Number: CN18263A3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/12/2019
• Date Report to Manufacturer: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31390 DA