MAUDE Adverse Event Report: UNKNOWN GOMCO CLAMP; CIRCUMCISION CLAMP

Device Problem Self-Activation or Keying (1557)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

During circumcision procedure, the gomco clamp self-released after the skin was cut circumferentially.Incision started to bleed.Pressure applied to site and bleeding stopped.Infant was discharged home the next day.

• Brand Name: GOMCO CLAMP
• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5115631
• MDR Text Key: 27216867
• Report Number: 5115631
• 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: Other
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Weight: 2