MAUDE Adverse Event Report: Medline Industries, LP SensiCare; GLOVE,EXAM,NITRILE,FG TOUCH, 300, S

Catalog Number	FG3001
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Rash (2033)
Date of Event	07/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6)2026 the individual had an "allergic reaction" described as a "rash" after using the product.Per the customer, the individual required "steroid cream" to treat the skin reaction.
Additional Manufacturer Narrative
It was reported that on (b)(6)2026 the individual had an "allergic reaction" described as a "rash" after using the product.Per the customer, the individual required "steroid cream" to treat the skin reaction.It has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: SensiCare
• Common Device Name: GLOVE,EXAM,NITRILE,FG TOUCH, 300, S
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50098626
• Report Number: 1417592-2026-08109
• Device Sequence Number: 10271341
• Product Code: LZA
• UDI-Device Identifier: 10888277362734
• UDI-Public: 10888277362734
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: FG3001
• Device Lot Number: ZIM512141583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2025
• 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 Age: 35 YR
• Patient Sex: Female