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

Model Number	02-01-0500
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples returned.The pictures shows scratches and the brass showing through.
Event or Problem Description
Distributor is reporting that their customer /customers are reporting that they are not getting a smooth cut around the bell, cutting the foreskin is not east and is causing concern from their doctors.

• 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; 1720 sublette ave; st. louis MO 63110
• Manufacturer Contact: nicole szakats ; 1720 sublette ave; st. louis, MO 63110 ; 3147712400
• MDR Report Key: 21180441
• Report Number: 1924066-2025-00005
• Device Sequence Number: 14524698
• Product Code: HFX
• UDI-Device Identifier: 00026072002308
• UDI-Public: (01)00026072002308(11)231220
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/16/2025

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: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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