MAUDE Adverse Event Report: GOMCO CIRCUMCISION CLAMP; GOMCO CLAMP 1.3 CM

Model Number 1013

Device Problem Unintended Movement (3026)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/23/2019

Event Type  malfunction  

Event Description

During circumcision, dimensions were determined and proper alignment occurred.Gomco clamp was tightened, while making incision clamp allowed for movement despite being fully tightened.Pt required pressure, dermabond for bleeding.

• Brand Name: GOMCO CIRCUMCISION CLAMP
• Type of Device: GOMCO CLAMP 1.3 CM
• MDR Report Key: 9167493
• MDR Text Key: 161956967
• Report Number: 9167493
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/26/2019

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 Operator: No Information
• Device Model Number: 1013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/23/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA