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

Catalog Number MDS138000

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

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 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.".

• Type of Device: PACK,COLD,INSTANT,HEAVY-WEIGHT,6"X10"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10914004
• MDR Text Key: 220630063
• Report Number: 1417592-2020-00147
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10080196158522
• UDI-Public: 10080196158522
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS138000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention