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

Catalog Number	MDS138005
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the instant cold pack contents/liquids leaked from the pack's upper seam and end-user required eye irrigation.

• Common Device Name: PACK,COLD,INSTANT,HEAVY-WEIGHT,6"X10"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8409512
• Report Number: 1417592-2019-00022
• Device Sequence Number: 1955021
• Product Code: IMD
• UDI-Device Identifier: 10080196158522
• UDI-Public: 10080196158522
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/11/2019
• 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