MAUDE Adverse Event Report: FILSHIE CLIPS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Inadequate Pain Relief (2388); Abdominal Cramps (2543)

Event Date 03/17/2014

Event Type  Injury  

Event Description

I had a bilateral tubal ligation using filshie clips in 2014.I immediately got post tubal ligation syndrome and hormone shock.My periods began flooding and cramps felt like contractions.Forced to have hysterectomy due to pain.The doctor left the clips; however, now i'm left with severe and chronic pain and fibromyalgia.I'm (b)(6) and my quality of life has been severely affected.If it weren't for my family and friends, i would rather die than live in this pain forever.I was a fitness guru and extremely physically fit.Now light activity causes extreme pain.I'm often bed ridden.There horrible clips need to be taken off the market.

• Brand Name: FILSHIE CLIPS
• Type of Device: FILSHIE CLIPS
• MDR Report Key: 6080981
• MDR Text Key: 59355898
• Report Number: MW5065846
• Device Sequence Number: 2
• Product Code: KNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/03/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CYMBALTA; GABAPENTIN; NICORETTE; XL TRAMADOL; XR WELLBUTRIN
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 31 YR
• Patient Weight: 79