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

Model Number MDS139008

Device Problem Material Integrity Problem (2978)

Patient Problem Chemical Exposure (2570)

Event Date 10/04/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 302867417
• Report Number: 1417592-2022-00209
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDS139008
• Device Catalogue Number: MDS139008
• Device Lot Number: VN22039-1112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG