MAUDE Adverse Event Report: FEMCARE LTD. TITANIUM FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problems Emotional Changes (1831); Fatigue (1849); Nerve Damage (1979); Internal Organ Perforation (1987); Pain (1994); Burning Sensation (2146); Discomfort (2330); Sleep Dysfunction (2517); Dry Mouth (4485); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/18/2008

Event Type  Injury  

Event Description

Both of the filshie clips used in my tubal ligation migrated in my pelvis.I had not been given an informed consent.My gynecologist told me the clips were safe.I specifically asked.I felt the first signs/symptoms six years post op.I had rectal tingling after long car rides that went away.Ten months after a colonoscopy (suggested by (b)(6) gp who thought i had tenesmus), i drove to work one afternoon and arrived with my rectum electrocuted.I could not sit.A clip bore through my intestine and lodged itself under the neck of my bladder.The other clip migrated to my rectum.They were seen on an mri.The clips stretched my pudendal nerve and it became 'entrapped' between two ligaments in my ischial spine.My doctor and every specialist she sent me to gas lighted me.I was not properly examined by any of them.Physiotherapy made it worse.I couldn't lie down and thus i couldn't sleep.The pain was burning torture.I was told i'd be seen in a pain clinic.I wasn't.The doctors did not follow the standard of care for a patient with a pinched pudendal nerve.I was seen on a medicine ward.The interventional pain specialist i was sent to did not give me pain clinic intake forms to fill out.She listened to nothing i had to say, she did her nerve blocks incorrectly, she changed my diagnosis from pudendal nerve entrapment to vulvodynia.Not one medicine she gave me helped get rid of the severe neuritis.I suffered for 3.5 years and i had my nerve released in (b)(6) 3.5 years too late.I procured the decompression surgery because i paid a registered nurse consultant to advocate for me.I was going to die from severe sleep deprivation and uncontrolled pain.I did not recover after the (b)(6) surgery because the clips were where they were.I had severe flare ups for seven more years until the clip on my rectum was finally removed in 2017 and the clip under my bladder was removed in (b)(6) 2018.I have not recovered.I am disabled.I cannot work (i lost a career and job of 31 years), i cannot sit in any comfort.I cannot sleep in any comfort.I cannot lift anything heavy.I require medications that cause dry mouth and fatigue for the rest of my life.My c-reactive protein was the highest my gp had ever seen in any patient.Instead of helping me with whatever was going on biochemically, she crossed the barrier between us, put her face right in front of mine and at the top of her lungs she yelled, "do you smoke!" i don't smoke, they are cancer sticks, they are a waste of money, they cause wrinkles, they stain teeth.I do not know why my gp turned on me after that.Fda safety report # (b)(4).

• Brand Name: TITANIUM FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 12814451
• MDR Text Key: 280910644
• Report Number: MW5105315
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BOSWELLIA; COMPOUNDED VALIUM ; LIDOCAINE SUPPOSITORIES; MAGNESIUM ; NORTRIPTYLINE; PASSIONFLOWER; TOVIAZ ; VALERIAN; ZOPICLNE
• Patient Outcome(s): Disability; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White