MAUDE Adverse Event Report: MEDLINE HOT THERAPY LARGE HOT PACK; PACK, HOT

Catalog Number MDS139009

Device Problems Burst Container or Vessel (1074); Expulsion (2933)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  malfunction  

Event Description

Employee had difficulty activating hot pack.With continued manipulation to activate hot pack, the hot pack and contents exploded onto employee.Employee was not injured.No patient was involved.

• Brand Name: HOT THERAPY LARGE HOT PACK
• Type of Device: PACK, HOT
• Manufacturer (Section D): MEDLINE; 1 medline place; mundelein IL 60060
• MDR Report Key: 6089169
• MDR Text Key: 59493671
• Report Number: 6089169
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS139009
• Device Lot Number: CN16006A1
• Other Device ID Number: THERE IS NO EXPIRATION DATE O
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO