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

Catalog Number	MDS9900025K
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when mogen pulled back to adjust placement, there appeared to be a laceration on the left side of the newborns penis during circumcision.".
Additional Manufacturer Narrative
The reported issue was that when the mogen was pulled back to adjust placement, there appeared to be a laceration on the left side of the newborn's penis during circumcision; "additional bleeding" was reported, the area was wrapped with gauze, and no medical intervention, serious injury, or follow-up care has been reported.Medline requested the lot number and return of the product/photos; at this time, a sample was not received for investigation, no lot/serial number was provided by the account, and the investigation included review of recent complaint trends/scar activity for the last three trend reports.The complaint was not confirmed due to the fact that this issue can only be confirmed by further investigating the sample or a provided photo; no root cause was identified, and the cause was updated to unconfirmed defect - sample required to determine cause.If the sample(s) is received at a later date, this investigation will be reopened and additional details will be provided; division will continue to monitor trends.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: aaron ginsburg ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50915873
• Report Number: 1417592-2026-52056
• Device Sequence Number: 5778591
• Product Code: HFX
• UDI-Device Identifier: 10197344003075
• UDI-Public: 10197344003075
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 09/25/2026

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: MDS9900025K
• 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: 07/08/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male