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	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint was received alleging that a clamp was flaking.The suspect device was returned for evaluation.Visual inspection of the device identified surface flaking, which may be indicative of a plating-related issue.
Event or Problem Description
Flaking.

• 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: 24225332
• Report Number: 1924066-2026-00002
• Device Sequence Number: 8392824
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: 00026072002308
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/30/2026

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: 0325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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