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

Catalog Number MDS139009

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Eye Injury (1845); Chemical Exposure (2570)

Event Date 05/03/2018

Event Type  Injury  

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 Description

It was reported that the employee "twisted the bag" to activate the hot pack and its contents contacted the employee's right eye.

• Type of Device: PACK,HOT,INSTANT,LRG,6X9
• 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: 7529818
• MDR Text Key: 108772905
• Report Number: 1417592-2018-00039
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: MDS139009
• Device Lot Number: CN1728883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/21/2018
• 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: 40 YR
• Patient Weight: 82