MAUDE Adverse Event Report: ALLIED MEDICAL LLC. GOMCO; 500S CIRC CLAMP, NEWBORN 1.3

Model Number	02-01-0500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples returned.Cannot determine the validity of the complaint.
Event or Problem Description
The customer removed the manufacturer date stickers to sterilize the clamp prior to use and they said the finish came off with the sticker.

• Brand Name: GOMCO
• Common Device Name: 500S CIRC CLAMP, NEWBORN 1.3
• Manufacturer (Section D): ALLIED MEDICAL LLC.; 13622 lakefront drive; st. louis MO 63045
• Manufacturer (Section G): ALLIED MEDICAL LLC; 13622 lakefront drive; st. louis MO 63045
• Manufacturer Contact: nicole szakats ; 13622 lakefront drive; st. louis, MO 63045 ; 3147712400
• MDR Report Key: 23328893
• Report Number: 1924066-2025-00080
• Device Sequence Number: 21485818
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: (01)00026072002308(11)250402
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 20250402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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