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

Model Number	MDS139008
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	10/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 10/04/22 a hot pack was brought into the patient room and when the staff member attempted to activate the pack, 'the pack exploded from the top seam,' and got into the staff members eyes.Per the facility the staff member used the eye wash station immediately and went to the emergency room.Per the facility the staff member received additional eye flushes, ph testing, and eye dilation to test for corneal abrasions while in the emergency room.Per the facility the staff member is reported to have, 'no issues now'.The sample is not available to be returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(4) 2022 a hot pack was brought into the patient room and when the staff member attempted to activate the pack, 'the pack exploded from the top seam,' and got into the staff members eyes.

• Brand Name: Medline
• Common Device Name: PACK,HOT,INSTANT,MED ,6X6"
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15716163
• Report Number: 1417592-2022-00209
• Device Sequence Number: 20115446
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: MDS139008
• Device Catalogue Number: MDS139008
• Device Lot Number: VN22039-1112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG