MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,COLD,INSTANT,HEAVY-WEIGHT,6"X10"

Catalog Number	MDS138000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on (b)(6) 2020 that an accu-therm instant heavy-weight jr.Cold pack "had explode open, and went all over the walls, ceiling, and sprayed into the eyes of a nurse.Had to send her to employee health.They were squeezing it to get it to liquefy." the reporter did not specify the date that this incident had occurred, for this report (b)(6) 2020 will be input for date of incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident and in abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, an accu-therm instant heavy-weight jr.Cold pack "had explode open, and went all over the walls, ceiling, and sprayed into the eyes of a nurse.".

• Common Device Name: PACK,COLD,INSTANT,HEAVY-WEIGHT,6"X10"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10914004
• Report Number: 1417592-2020-00147
• Device Sequence Number: 13680484
• Product Code: IMD
• UDI-Device Identifier: 10080196158522
• UDI-Public: 10080196158522
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

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: MDS138000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/27/2020
• 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: Required Intervention