MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/19/2015

Event Type  Injury  

Event Description

(b)(4).Out of fallopian tube, adjacent to my ascending colon.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6353898
• MDR Text Key: 68165160
• Report Number: MW5068083
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NONE....
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 35.000 YR