MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Pain (1994); Chills (2191); Irritability (2421); Weight Changes (2607)

Event Date 04/03/2003

Event Type  Injury  

Event Description

(b)(4).I had these filshie clips put into my body 14 years ago and its been horrible.I was told the only side effect that was possible is ectopic pregnancy.I asked about any other side effects and i was told none.The following is a list of side effects that i've suffered with the last 14 years of my life: hot flashes, chills, irritability, mood swings, trouble sleeping (either falling asleep or staying asleep), loss of libido, itchy vagina (without a yeast infection), crashing fatigue, feelings of dread, memory lapses, itchy, crawly skin (been on zyrtec due to hives for a metal allergy), aching, sore joints and amp; muscles/tendons, tension in muscles, breast tenderness, decreased breast mass, headaches (the week of menstruation), sudden bouts of bloat, gas pain, indigestion, exacerbation of existing conditions, chronic sinuitis, nasal infections necessitating antibiotics, weight gain ((b)(6)), increase in facial hair, changes in body odor, stabbing pains in pelvic area.These side effects have affected my daily life.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6497088
• MDR Text Key: 72920104
• Report Number: MW5069112
• 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: 04/16/2017

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: 04/17/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40.000 YR