MAUDE Adverse Event Report: AVALON MEDICAL CORPORATION / FEMCARE LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Hot Flashes/Flushes (2153); Anxiety (2328); Depression (2361); Reaction (2414); Weight Changes (2607); Heavier Menses (2666); No Code Available (3191)

Event Date 08/03/2020

Event Type  Injury  

Event Description

Filshie clips.The filshie clips have came off one of my tubes and had migrated into my pelvic area causing a great deal of pain.I have to get these removed in order for the pain to go away and from causing anymore problems.When having a tubes "tied" i was never told about the clips.After having my tubes tied, i have had side effects: depression, anxiety, weight gain, ibs, pain in my right side, hot flashes, fatigue, very heavy periods, loss of libido, memory lapse, brain fog, facial hair increase in allergies.The filshie clips are not okay.I see the recalls the support groups for women that have went through this and that are still going through it.We need help, i will be having my surgery soon to get these removed.That surgery alone is (b)(6).This does not include all of the hospital/ doctors appt visits prescriptions time off of work.These filshie clip need to be taking off the market and investigated before putting them in people's bodies.Fda safety report id# (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): AVALON MEDICAL CORPORATION / FEMCARE LTD.
• MDR Report Key: 10487742
• MDR Text Key: 205676107
• Report Number: MW5096409
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• 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: 09/01/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 91