MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Emotional Changes (1831); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Cramp(s) (2193); Dizziness (2194); Anxiety (2328); Depression (2361); Weight Changes (2607)

Event Date 03/07/2007

Event Type  Injury  

Event Description

(b)(4).In (b)(6), i was due to deliver my son; at my doctors appt, she explained i was dilated to 2 and she was sending me to hosp.And then gave me papers to sign for my tubal to sign.At an earlier appt, i said that i wanted my tubes cut snip typed and burnt but never discussed it any further.After his birth, i followed with the tumble but was not informed about the clips.I have just now found out that i have clips in areas that are painful constantly.Cramping shooting or stabbing pain.Also i was walking at a flea market and picked up my son to have a large bubble gum bubble come around my rib on the right side.I pushed it back in and my husband put aace wrap around me.I have also cold flashes and hot flashes daily, i cry for no reason , or depression.I have dizzy spells when i stand up , sometimes every time i stand and times i go days w/o getting dizzy.I stay constipated, i take stool softeners daily just to possibly poop.I have headaches when i wake every day.About a year ago, i thought i was dying, couldn't breath and the emt said it was anxiety from my bp.I fell fatigue, a lot tired /sick, no energy.I have gained belly weight , only that i don't know why no changes in life situation.It hurt just about constantly in my belly on the right side or across the pelvis both sides.I have 2 periods a month , my breast have decreased in size drastically and always hurt.I have memory lapses , i forgot where i was going one day pulled over figured out where i was going via phone , drove off and forgot again.Things that wouldn't forget sometimes i just can't think of but i know it.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6392291
• MDR Text Key: 69512193
• Report Number: MW5068354
• 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: 02/25/2017

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: 03/09/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 38.000 YR