MAUDE Adverse Event Report: UNKNOWN GOMCO USA GOMCO CLAMP; CLAMP, CIRCUMCISION

Model Number 1.3

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/07/2020

Event Type  malfunction  

Event Description

Gomco clamp with no size label on bell.Bell was loose at connection to clamp.Physician did circumcision and baby had more bleeding than normal requiring application of surgicell.Bleeding stopped.(brand gomco usa - gomco 1.3 clamp).Fda safety report id #: (b)(4).

• Brand Name: GOMCO USA GOMCO CLAMP
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10257648
• MDR Text Key: 198694692
• Report Number: MW5095481
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 DA
• Patient Weight: 2