MAUDE Adverse Event Report: UNKNOWN; GOMCO CLAMP

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331)

Event Date 08/26/2015

Event Type  malfunction  

Event Description

During circumcision of child, the gomco clamp per physician was defective and became detached during the procedure.Child had significant bleeding and sutures were placed.

• Brand Name: UNKNOWN
• Type of Device: GOMCO CLAMP
• MDR Report Key: 5210458
• MDR Text Key: 30886090
• Report Number: MW5057742
• Device Sequence Number: 1
• Product Code: HFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 DA