MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC. 306 CLAMP GOMCO 1.1; CLAMP, CIRCUMCISION

Lot Number TM2312/2022/ROD

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/21/2024

Event Type  malfunction  

Event Description

Gomco used during circumcision did not provide hemostasis and the circumcision bled requiring surgicel placement.

• Brand Name: CLAMP GOMCO 1.1
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC. 306
• MDR Report Key: 19206510
• MDR Text Key: 341490941
• Report Number: MW5154380
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Lot Number: TM2312/2022/ROD
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male