MAUDE Adverse Event Report: ELMED INCORPORATED ELMED INCORPORATED; GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2")

Model Number	ST315502
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Have requested the user to send back the device for evaluation.Have received product back and it is undergoing review and inspection for intended functionality.
Event or Problem Description
Item: st315502.Gomco style circumcision clamp, newborn 1.3 cm (1/2").Per the customer, when the bell was seated, it was loose.This created an incomplete hemostasis, resulting in bleeding after circumcision.No additional injury was reported by the customer.

• Brand Name: ELMED INCORPORATED
• Common Device Name: GOMCO STYLE CIRCUMCISION CLAMP, NEWBORN 1.3 CM (1/2")
• Manufacturer (Section D): ELMED INCORPORATED; 35 n brandon dr; glendale heights IL 60139
• Manufacturer (Section G): ELMED INCORPORATED; 35 n brandon dr.; glendale heights IL 60139
• Manufacturer Contact: sabine hausner ; 35 n brandon dr.; glendale heights, IL 60139 ; 2243536446
• MDR Report Key: 21062533
• Report Number: 1412854-2024-12241
• Device Sequence Number: 3409714
• Product Code: HFB
• UDI-Device Identifier: 00198506002632
• UDI-Public: 00198506002632
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D543830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/23/2024

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
• Operator of Device: Health Professional
• Device Model Number: ST315502
• Device Catalogue Number: ST315502
• Device Lot Number: E0824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose