MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE HOT/COLD PACKS (DISPOSABLE); PACK, HOT OR COLD, DISPOSABLE

Lot Number MDS139008

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

Medline hot pack exploded upon activation.Manufacturer response for hot pack, (brand not provided) (per site reporter) : our materials management team has notified the rep from medline to initiate a qa review.The defective product will be returned for analysis via our materials team.

• Brand Name: MEDLINE HOT/COLD PACKS (DISPOSABLE)
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8280903
• MDR Text Key: 134232825
• Report Number: 8280903
• 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: 01/04/2019

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: Health Professional
• Device Lot Number: MDS139008
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1