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

Catalog Number MDS138010

Device Problem Burst Container or Vessel (1074)

Event Date 07/23/2023

Event Type  Injury  

Event Description

Ice pack contents in eye requiring intervention.

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.

• Type of Device: 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
• MDR Text Key: 321288718
• Report Number: 1417592-2023-00345
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10080196158577
• UDI-Public: 10080196158577
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other