MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP FITGUARD; GLOVE, EXAM, NITRILE, PF, LF, M

Catalog Number	TRG400M
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	04/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "a team member experienced irritation" and "has developed visible rashes on both hands" after using the product.The facility reported "cortisone cream was applied" to manage symptoms.The individual subsequently "visited the emergency room and received steroids" for treatment and "to soothe the areas".The individual was reported to be doing "better after being provided with sensitive gloves." the facility reported, "due to the visible nature of the rash and ongoing discomfort, this raises concerns for product sensitivity." no additional information is available at this time.A sample has been requested for evaluation.It has been determined that the reported event caused or contributed to a serious injury requiring medical intervention, therefore, 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, "a team member experienced irritation" and "has developed visible rashes on both hands" after using the product.

• Brand Name: FITGUARD
• Common Device Name: GLOVE, EXAM, NITRILE, PF, LF, M
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25161843
• Report Number: 1417592-2026-01213
• Device Sequence Number: 15618515
• Product Code: LZA
• UDI-Device Identifier: 10888277400580
• UDI-Public: 10888277400580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051378
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Catalogue Number: TRG400M
• Device Lot Number: AN504388506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: Female