MAUDE Adverse Event Report: Medline Industries, LP CURAD; GLOVE,EXAM,LATEX,CURAD,PF,MD

Catalog Number	CUR8105
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lab is experiencing issues with the cur8105.They are splitting and ripping.
Additional Manufacturer Narrative
The customer reported curad latex exam gloves were splitting/ripping, and the complaint transcript stated the issue did not occur during use and no injury occurred.No sample was available, but the issue could be identified via the customer supplied image; the vendor investigation reviewed batch records and retention samples, and no defects or abnormalities were identified.Based on the results of the investigation, medline was unable to confirm the complaint issue nor that the product failed to meet specifications.The root cause was suspected to be that the glove contains a micro hole, likely resulting from a "hole-touching" defect; no adverse trending was identified and there was no need for further action such as initiation of capas, scars and/or other risk management activities at this time.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: CURAD
• Common Device Name: GLOVE,EXAM,LATEX,CURAD,PF,MD
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: pranayreddy alluri ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50945355
• Report Number: 1417592-2026-54063
• Device Sequence Number: 15836346
• Product Code: LYY
• UDI-Device Identifier: 10080196319176
• UDI-Public: 10080196319176
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161833
• 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): 09/25/2026

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: CUR8105
• Device Lot Number: KOB412948813
• 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: 08/28/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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