MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP SENSICARE; GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,6.5

Catalog Number	MSG6365
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer, the individual experienced "redness, itching, and swelling" beginning in the "summer of 2025" while using the gloves.The customer reported that the irritation occurred "on and off" while using the product but worsened in (b)(6) of 2026 causing the individual to seek medical attention.The customer reported that they were prescribed "an oral medication and cream to apply to the area".The customer reported that after taking the prescribed medications and stopping use of the product, the "dermatitis" was no longer "visible or itchy".The customer did not report any serious injury related to the reported incident.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 or Problem Description
According to the customer, the individual experienced "redness, itching, and swelling" beginning in the "summer of 2025" while using the gloves.The customer reported that the irritation occurred "on and off" while using the product but worsened in (b)(6) of 2026 causing the individual to seek medical attention.
Additional Manufacturer Narrative
Update to d9: sample returned.Update to h3: device evaluated.Update to h6: type of investigation.Update to h6: investigation findings.

• Brand Name: SENSICARE
• Common Device Name: GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,6.5
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24322310
• Report Number: 1417592-2026-00107
• Device Sequence Number: 18600966
• Product Code: KGO
• UDI-Device Identifier: 10193489000030
• UDI-Public: 10193489000030
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192820
• 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,Followup
• Report Date (Section B): 04/08/2026

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: Other
• Device Catalogue Number: MSG6365
• Device Lot Number: 5042161665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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: Unknown