MAUDE Adverse Event Report: CAREFUSION, INC MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN; CLAMP, CIRCUMCISION

Catalog Number GL7021

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348); Blood Loss (2597)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).This complaint was opened from the medwatch report and has no contact information so the customer could not be reached for further information.Device not available.

Event Description

Medwatch report mw5078294 states: excessive bleeding following circumcision using mogen clamp.Tip of glans amputated during procedure.Infant transferred to nicu to monitor bleeding.Required plastic surgery repair/glans reattachment and foley catheter for one month during healing process.The sample, pictures, and lot number are not available.Also, there is no contact information from this complaint so we have no way of gathering further information.

Event Description

Excessive bleeding following circumcision using mogen clamp.Tip of glans amputated during procedure.Infant transferred to nicu to monitor bleeding.Required plastic surgery repair/glans reattachment and foley catheter for one month during healing process.

Manufacturer Narrative

The sample, lot number, and contact information was not provided so the evaluation was based off the minimal information provided.The root cause of the reported issue is undetermined.There have been no issues identified with the material or manufacturing process.Device not available.

• Brand Name: MOGEN CIRCUMCISION CLAMP 2-7/8X1-1/2IN
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 7748237
• MDR Text Key: 115966979
• Report Number: 1423507-2018-00013
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: GL7021
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability