MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,EXAM,NITRILE,RESTORESENSE,GREEN,XS

Catalog Number	OAT4583H
Medical Device Problem Codes	Biocompatibility (2886); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Rash (2033); Contact Dermatitis (4546)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GLOVE,EXAM,NITRILE,RESTORESENSE,GREEN,XS
• Manufacturer (Section D): Medline Industries, LP
• Manufacturer Contact: vineet pandya ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50788176
• Report Number: 1417592-2026-42073
• Device Sequence Number: 10571357
• Product Code: LZA
• UDI-Device Identifier: 00888277705145
• UDI-Public: 00888277705145
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K192315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: OAT4583H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown