MAUDE Adverse Event Report: COOPER SURGICAL FILSHIE CLIPS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Incontinence (1928); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Hot Flashes/Flushes (2153); Chills (2191); Dizziness (2194); Anxiety (2328); Depression (2361); Irritability (2421); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 04/17/2017

Event Type  Injury  

Event Description

(b)(4).Hot flashes, night sweats, flushes, cold flashes, bouts of rapid heartbeat, irritability, mood swings, sudden tears, trouble sleeping through the night, irregular periods: shorter and lighter, or heavier and longer, loss of libido, dry vagina, chronic fatigue, anxiety, feelings of dread, difficulty concentrating, mental confusion, disturbing memory lapses, incontinence, aching, sore joints, muscles or tendons, breast tenderness, decrease in breast mass, headache change: increased or decreased, depression, weight gain, hair loss or thinning, dizziness, pelvic pain, i literally have all of these symptoms and i am in almost everyday constant pain.

• Brand Name: FILSHIE CLIPS
• Manufacturer (Section D): COOPER SURGICAL
• MDR Report Key: 6497104
• MDR Text Key: 72919689
• Report Number: MW5069117
• 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: 04/17/2017

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
• Treatment: FILSHIE CLIPS
• Patient Outcome(s): Other
• Patient Age: 38.000 YR