MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION GOMCO 1.1; CLAMP, CIRCUMCISION

Lot Number 2019061801

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2019

Event Type  malfunction  

Event Description

Physician used a 1.1 gomco lot number 201906180 to perform a circumcision.The gomco itself removed the foreskin and the provider did not have to use a scalpel to remove it.This is not an intended action of the gomco itself.Fda safety report id# (b)(4).

• Brand Name: GOMCO 1.1
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION
• MDR Report Key: 8807659
• MDR Text Key: 151729245
• Report Number: MW5088241
• 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: Other
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2019061801
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1