MAUDE Adverse Event Report: WESCO INTERNATIONAL COLDSTAR; INSTANT HEAT PACK

Catalog Number 1301

Device Problem Burst Container or Vessel (1074)

Patient Problems Inflammation (1932); Pain (1994); Red Eye(s) (2038); Blurred Vision (2137)

Event Date 09/18/2016

Event Type  Injury  

Event Description

Pt twisted the heat pack, while trying to activate, and caused the package to burst.Subsequently, some of the contents splashed into the pt's left eye.Eye was flushed with saline as needed.On (b)(6) 2016 (b)(4), physical exam, eyes; denies blurry vision, conjunctival inflammation, eye lid inflammation, pain, redness or vision changes.Inspection was normal.(b)(4).

• Brand Name: COLDSTAR
• Type of Device: INSTANT HEAT PACK
• Manufacturer (Section D): WESCO INTERNATIONAL
• MDR Report Key: 5979830
• MDR Text Key: 55831738
• Report Number: MW5065038
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 67