MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; PACK,COLD,INSTANT,STANDARD,6"X9"

Model Number	MDS137000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 after activating the cold pack "according to instructions on the pack", the cold pack was place on the patient's right side of her nose when the pack leaked, and went into the patient's mouth.The customer reported they are uncertain if it went into her eyes and the patient "didn't swallow the liquid".The customer reported they rinsed the mouth with water and rinsed the eyes with normal saline.The customer reported there is "no harm that we know of" related to the reported incident.Sample requested to be returned.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.Reported to healthcanada under reporter file number (b)(4).
Event or Problem Description
According to the customer, on (b)(6) 2023 after activating the cold pack "according to instructions on the pack," the cold pack was place on the patient's right side of her nose when the pack leaked, and went into the patient's mouth.

• Brand Name: Medline
• Common Device Name: PACK,COLD,INSTANT,STANDARD,6"X9"
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16462590
• Report Number: 1417592-2023-00084
• Device Sequence Number: 6573176
• Product Code: IMD
• UDI-Device Identifier: 00080196732336
• UDI-Public: 00080196732336
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/01/2023

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
• Device Model Number: MDS137000
• Device Catalogue Number: MDS137000
• Device Lot Number: RA22227CAN1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/01/2023
• 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 Sex: Unknown