MAUDE Adverse Event Report: ALLIED MEDICAL LLC. GOMCO; 500 CIRC CLAMP,NEWBORN,

Model Number	02-01-0500
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received alleging that a clamp was defective.Photographs provided by the complainant showed surface irregularities and wear around the plate opening for the bell that appeared inconsistent with the expected condition of the device.The clamp was identified as having a manufacturing date of december 2023.The device was not returned for evaluation; therefore, the investigation was limited to a review of the images provided.Based on the visual evidence available, the observed surface condition may be consistent with suboptimal plating.However, in the absence of the physical device, no definitive conclusions regarding the device condition or root cause could be confirmed.
Event or Problem Description
As per client, the circumcision clamps they ordered seem to be defective.

• Brand Name: GOMCO
• Common Device Name: 500 CIRC CLAMP,NEWBORN,
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 1720 sublette ave; st. louis MO 63110
• Manufacturer (Section G): ALLIED MEDICAL LLC; 13622 lakefront drive; erath city MO 63045
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; earth city, MO 63045 ; 3147712400
• MDR Report Key: 24225331
• Report Number: 1924066-2026-00001
• Device Sequence Number: 8392823
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: 00026072002308
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/29/2026

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: 02-01-0500
• Device Catalogue Number: 02-01-0500
• Device Lot Number: 1223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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