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

Catalog Number MDS139008

Device Problem Burst Container or Vessel (1074)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/22/2019

Event Type  malfunction  

Event Description

Nurse attempted to show patient how to activate medline heating pack, during which it popped and released contents on patient and patient's bed.Small piece landed in patient's nose, which ended up being swallowed.Poison control contacted, instructed to have patient drink water and that may cause stomach upset.Patient had no gastrointestinal upset symptoms related to incident.

• 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: 8811393
• MDR Text Key: 151724220
• Report Number: 8811393
• 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: 06/28/2019

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: No Information
• Device Catalogue Number: MDS139008
• Device Lot Number: CN19047B9
• 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: 06/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Weight: 53