MAUDE Adverse Event Report: SKLAR CLAMPS; CLAMP, CIRCUMCISION

Model Number 85-6550

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2023

Event Type  malfunction  

Event Description

The clamp is extremely difficult to release once applied and could harm patient during use.

• Brand Name: SKLAR CLAMPS
• Type of Device: CLAMP, CIRCUMCISION
• MDR Report Key: 17388400
• MDR Text Key: 319754914
• Report Number: MW5119959
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 85-6550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian