MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; COLD PACK,INSTANT,TGT,6X8, 2/BX,24 BX/CS

Catalog Number TGT0104RR

Device Problem Burst Container or Vessel (1074)

Patient Problem Eye Injury (1845)

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that end-user squeezed and popped the instant cold pack for it to activate.The instant cold pack reportedly exploded and it contacted end-user's both eyes, which underwent laser surgery four months ago prior to this incident.The end-user stated that she immediately used the eye wash station and went to her eye doctor who prescribed her with an unknown antibiotic ointment to be applied for 7 days.It was not noted which part of the instant cold pack the contents leaked/exploded from.Due to the reported need for antibiotic ointment treatment and in an abundance of caution, this medwatch is being filed.The sample was not available to be returned for evaluation.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 exploded and its contents reached end-users eyes requiring antibiotic ointment.

• Type of Device: COLD PACK,INSTANT,TGT,6X8, 2/BX,24 BX/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 7802685
• MDR Text Key: 118106999
• Report Number: 1417592-2018-00093
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2018

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: Lay User/Patient
• Device Catalogue Number: TGT0104RR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 38 YR
• Patient Weight: 68