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

Model Number MDS139008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body Sensation in Eye (1869)

Event Date 09/05/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2022 when using the hot pack the 'rn activated heat pack and contents shot out of the top and went into patient's eye'.According to the customer 'a new pack was procured by rn for patient' and the patient's eye was 'flushed'.The customer reported, 'all are fine and with no residual issues'.The customer reported there has been no medical intervention or serious injury related to the product use in this reported incident.Sample not available.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.

Event Description

According to the customer, on (b)(6) 2022 when using the hot pack the 'rn activated heat pack and contents shot out of the top and went into patient's eye'.

• 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: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16148093
• MDR Text Key: 307193856
• Report Number: 1417592-2023-00022
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2022
• 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