MAUDE Adverse Event Report: MEDICON MOGEN CIRCUMCISION CLAMP; MEDICON MOGEN CIRCUMCISION CLAMP

Model Number GL7021

Device Problem Mechanics Altered (2984)

Patient Problem Tissue Damage (2104)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Device not yet evaluated , if the device is evaluated a follow up will be sent.Device evaluation in progress.

Event Description

Sales rep reported via email the circumcision clamp unintentionally cut the foreskin, rather than retracting/holding in place as it's intended to do.There was no harm to the patient, but the customer is concerned that there could have been under difference circumstances.The procedure that was being performed was a circumcision.There was no medical procedure performed or medical intervention required because of this incident.No adverse outcome.No further information.

Manufacturer Narrative

(b)(4).

• Brand Name: MOGEN CIRCUMCISION CLAMP
• Type of Device: MEDICON MOGEN CIRCUMCISION CLAMP
• Manufacturer (Section D): MEDICON; gaensaecker 15; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anton mittermueller ; gaensaecker 15; tuttlingen, 78532 ; GM 78532 ; 74622009
• MDR Report Key: 5646152
• MDR Text Key: 44889976
• Report Number: 8010099-2016-00001
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GL7021
• Device Catalogue Number: 51.99.50
• Device Lot Number: XMIV04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other