MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,MED ,6X6"

Catalog Number	MDS139008
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported via medwatch (b)(4) that the patient's mother informed the staff that a hot pack exploded in her face when she squeezed the bag to activate it.Reportedly the contents from inside the bag went into the mother's right eye and on her face.She rinsed her right eye well with water and normal saline.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during activation, a hot pack exploded in the end-users eye when she squeezed the bag to activate it.

• Common Device Name: PACK,HOT,INSTANT,MED ,6X6"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10896747
• Report Number: 1417592-2020-00146
• Device Sequence Number: 3254540
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: Lay User/Patient
• Device Catalogue Number: MDS139008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/24/2020
• 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