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

Catalog Number MDS139008

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  malfunction  

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 Description

It was reported that the staff member activated the hot pack by "punching" the product against a counter.

• Type of Device: PACK,HOT,INSTANT,MED ,6X6"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9649824
• MDR Text Key: 190760596
• Report Number: 1417592-2020-00007
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: MDS139008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/30/2020
• 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
• Patient Outcome(s): Other