MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CLAMP, MOGEN, CIRCUMCISION

Catalog Number	MDS9900025K
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the blade has cut the skin below where the clamp is placed.He says there is a sharp edge that is cutting the patient.".
Additional Manufacturer Narrative
The customer reported that during 4 circumcisions, the blade cut the skin below where the clamp is placed, and the reporter stated there is a sharp edge that is cutting the patient.A sample was received for investigation; visual and functional inspection was conducted, the simulated grip strength test was performed with a latex glove, and the item was measured with an opening of 2.3mm, which meets all the requirements and specifications.Based on the complaint details, sample evaluation and investigation, the complaint cannot be confirmed.After a functional inspection it was found that the item functions properly and meets all the specification.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: MEDLINE
• Common Device Name: CLAMP, MOGEN, CIRCUMCISION
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nicholas kourkine ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50589142
• Report Number: 1417592-2026-31540
• Device Sequence Number: 9586828
• Product Code: HFX
• UDI-Device Identifier: 10197344003075
• UDI-Public: 10197344003075
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K212911
• 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: MDS9900025K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2025
• 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: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown