MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; PACK,COLD,INSTANT,HEAVY-WT,JR,5X7

Catalog Number	MDS138010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Eye Irritation (4803)
Date of Event	07/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Ice pack contents in eye requiring intervention.
Additional Manufacturer Narrative
The customer reported when activating a cold pack "it exploded".It was reported that the contents got into the eye of the customer.Due to this an eye wash was performed but symptoms didn't resolve.It was reported that use of a morgan lens was needed due to persistent burning of the eye.After use of the morgan lens, it was reported that symptoms resolved.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: PACK,COLD,INSTANT,HEAVY-WT,JR,5X7
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17560220
• Report Number: 1417592-2023-00345
• Device Sequence Number: 19742842
• Product Code: IMD
• UDI-Device Identifier: 10080196158577
• UDI-Public: 10080196158577
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2023

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?: No
• Device Catalogue Number: MDS138010
• Device Lot Number: 48823050001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown