MAUDE Adverse Event Report: CONMED CORPORATION VCARE LARGE; CANNULA, MANIPULATOR, INJECTOR, UTERINE

Model Number 606085202A

Device Problem Inflation Problem (1310)

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

Event Date 03/27/2019

Event Type  Injury  

Event Description

User attempted to inflate the balloon and it would not hold air.Tried a second v-care device and it didn't hold air either.Fda safety report id# (b)(4).

• Brand Name: VCARE LARGE
• Type of Device: CANNULA, MANIPULATOR, INJECTOR, UTERINE
• Manufacturer (Section D): CONMED CORPORATION
• MDR Report Key: 8573403
• MDR Text Key: 143950136
• Report Number: MW5086319
• Device Sequence Number: 1
• Product Code: LKF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2020
• Device Model Number: 606085202A
• Device Lot Number: 201809101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 87