MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,LRG,6X9

Catalog Number	MDS139009
Health Effect - Clinical Codes	Eye Injury (1845); Chemical Exposure (2570)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the employee "twisted the bag" to activate the hot pack resulting in the hot pack exploding and its contents contacting the employee's right eye and chest.Per report, the employee was immediately taken to the emergency department where he needed his right eye irrigated due to a chemical burn from the hot pack's contents.There was no reported injury to the employee's chest.Reportedly, the employee followed-up the next day at the eye clinic and is scheduled to return for another follow-up.The employee is reportedly doing well at this time.It was reported that the event did not impact the patient.Due to the reported incident, this medwatch is being filed.The sample was not available to be returned for evaluation.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the employee "twisted the bag" to activate the hot pack and its contents contacted the employee's right eye.

• Common Device Name: PACK,HOT,INSTANT,LRG,6X9
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7529818
• Report Number: 1417592-2018-00039
• Device Sequence Number: 11186509
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2018

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
• Operator of Device: Other
• Device Catalogue Number: MDS139009
• Device Lot Number: CN1728883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/21/2018
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 82