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

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Tissue Damage (2104)

Event Date 12/21/2019

Event Type  Injury  

Manufacturer Narrative

It was reported by the facility that during a circumcision the circlamp closed at an angle resulting in a laceration to the infant's penis requiring medical intervention.The facility reports intervention required consisted of pedi-cauterizing to control bleeding and the utilization of surgifoam, and silver nitrate.According to the facility, the incident occurred on (b)(6) 2019.The infant was discharged home under normal newborn circumstances on (b)(6) 2019.The sample is not available for return and evaluation.No further information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that during a circumcision the circlamp closed at an angle resulting in a laceration to the penis requiring medical intervention.

• Type of Device: CIRCUMCISION CLAMP
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; three lakes drive; northfield, il
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, il ; 3585986
• MDR Report Key: 10008957
• MDR Text Key: 190936995
• Report Number: 1824619-2020-00008
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Weight: 3