MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Heavier Menses (2666)

Event Date 02/24/2017

Event Type  Injury  

Event Description

(b)(4).After i had the clips placed, which i was unaware of, i started having horrible, painful periods, most of the pain on my right side! my periods became so heavy i'm now anemic to the point of blood transfusion and will have to ultimately have a hysterectomy! i now have a stabbing pain in my cervix on my left side while in my period.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6356882
• MDR Text Key: 68268468
• Report Number: MW5068114
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2017

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NON
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 41.000 YR