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

Catalog Number MDS138005

Device Problem Leak/Splash (1354)

Patient Problem Eye Injury (1845)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the instant cold pack was activated "as per package instructions," was wrapped with a cloth and was applied to patient's eye/brow region for headache relief.Reportedly, the instant cold pack's contents/liquids leaked from the seams through the cloth and into the patient's bilateral eyes.Within couple of minutes, the patient reportedly complained of burning and pain to his right eye.Per report, the patient's eyes were immediately flushed and irrigated and after this, the patient's symptoms resolved.Due to the reported incident and medical intervention required, this medwatch is being filed.The sample was returned for evaluation and the complaint of failed seal was confirmed.A potential root cause, which could have caused the instant cold pack's seal to fail, is excessive pressure from activating the instant cold pack.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the instant cold pack contents/liquids leaked from the pack's upper seam and end-user required eye irrigation.

• Type of Device: PACK,COLD,INSTANT,HEAVY-WEIGHT,6"X10"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8409512
• MDR Text Key: 138807828
• Report Number: 1417592-2019-00022
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS138005
• Device Lot Number: CN18263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention