MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Detachment Of Device Component (1104)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Sweating (2444); Weight Changes (2607); Foreign Body In Patient (2687)

Event Date 11/13/2015

Event Type  Injury  

Event Description

(b)(4).I had these clips put in and had constant pain in left and right side couldn't do any of my activities as normal in and out of hospitals and doctors with fevers pain night sweats weight gain and infections.Ended up having another surgery (b)(6) 2017 to remove tubes both clips had fallen off one embedded in my right ovary the other they couldn't find.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6353343
• MDR Text Key: 68161058
• Report Number: MW5068073
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 23.000 YR