MAUDE Adverse Event Report: ALLIED MEDICAL LLC. GOMCO; 500S CIRC. CLAMP EX SMALL 1.1

Model Number	02-00-0500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received involving a circumcision clamp that reportedly caused a small cut to the foreskin during use.No long-term complications or serious injury have been reported.The device has not been returned for evaluation; therefore, the root cause of the event cannot be determined at this time.Follow-up activities are ongoing to obtain the device and additional information related to the event.
Event or Problem Description
I recently ordered 5 new gomco 1.1 circumcision devices at the end of (b)(6).They were placed in rotation last week and i had a physician to use two of them and reported that both times, the device caused a small cut to the foreskin while in use.

• Brand Name: GOMCO
• Common Device Name: 500S CIRC. CLAMP EX SMALL 1.1
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 13622 lakefront drive; earth city MO 63045
• Manufacturer (Section G): ALLIED MEDICAL LLC; 13622 lakefront drive; earth city MO 63045
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; earth city, MO 63045 ; 3147712400
• MDR Report Key: 25124643
• Report Number: 1924066-2026-00007
• Device Sequence Number: 8635052
• Product Code: HFX
• UDI-Device Identifier: 00026072002292
• UDI-Public: 00026072002292
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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 Model Number: 02-00-0500
• Device Catalogue Number: 02-00-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/08/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown