MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,MED ,6X6"

Catalog Number	MDS139008
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the staff member activated the hot pack by "punching" the product against a counter.The staff member diagnosed with tendonitis.The reporting facility indicated that the staff member was activating the hot pack "not per directions." despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional information to the manufacturer.No medical intervention or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported diagnosis of tendonitis, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the staff member activated the hot pack by "punching" the product against a counter.

• Common Device Name: PACK,HOT,INSTANT,MED ,6X6"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9649824
• Report Number: 1417592-2020-00007
• Device Sequence Number: 1767167
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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
• Operator of Device: Health Professional
• Device Catalogue Number: MDS139008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other