MAUDE Adverse Event Report: COOPERSURGICAL, INC. EURO-MED TENACULUM

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 06/06/2016

Event Type  Injury  

Event Description

During a leep procedure, the pt was somehow burned.Instruments involved included: sklar lateral retractor #(b)(4), euro-med vaginal speculum #(b)(4), euro-med tenaculum #(b)(4).

• Brand Name: EURO-MED TENACULUM
• Type of Device: TENACULUM
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 6066335
• MDR Text Key: 58845339
• Report Number: MW5065681
• Device Sequence Number: 3
• Product Code: HGC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1