MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; WARMER,HEEL,INFANT,GEL PK,100CS

Catalog Number MDS138007

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 03/02/2023

Event Type  Injury  

Manufacturer Narrative

Customer reported a "patient was found with an opened hot pack in his mouth".It was not confirmed if the contents of the pack were ingested, however poison control was called and they were advised to have patient "swish and spit x 3".Stomach and mouth "irritation" was noted in the details provided by the customer.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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

Open pack in mouth.

• Type of Device: WARMER,HEEL,INFANT,GEL PK,100CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16564651
• MDR Text Key: 311491729
• Report Number: 1417592-2023-00109
• Device Sequence Number: 1
• Product Code: IMD
• 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: 03/17/2023

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 Catalogue Number: MDS138007
• Device Lot Number: VN22182
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/17/2023
• 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