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

Lot Number 69718070005

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

Numerous (10) medline cold packs burst upon activation.All same lot number.No harm to patient or staff.Manufacturer response for cold pack, (brand not provided) (per site reporter): our materials management team has notified the rep from medline to initiate a qa review.Any defective product saved 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: 8280918
• MDR Text Key: 134233282
• Report Number: 8280918
• 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: 69718070005
• 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