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	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the flat pieces of this device that actually touches the foreskin have a sharp edge on them.When the physician clamps down on the foreskin, it cuts the skin by just closing the clamp.It cuts it on the underside of the penis.".
Additional Manufacturer Narrative
The account reported finding device cut the under skin; it was also reported that when the physician clamps down on the foreskin, it cuts the skin by just closing the clamp, on the underside of the penis.A sample was received for the investigation; functional inspection was conducted with the provided sample, and it was found that the item function properly, and simulated grip strength testing with a latex glove found the glove was not cut or teared.The opening was measured as 2.3mm, which meets all the requirements and specifications, and based on the complaint details, sample evaluation and investigation, the complaint cannot be confirmed.The cause was not confirmed with received sample, and the supplier quality team will monitor this issue for trending purposes.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: vamshi thupakula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50855299
• Report Number: 1417592-2026-47684
• Device Sequence Number: 9923512
• Product Code: HFX
• UDI-Device Identifier: 10197344003075
• UDI-Public: 10197344003075
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/22/2026

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: 03/24/2025
• 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: 03/11/2025
• Initial Report FDA Received Date: 09/22/2026
• 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