FILSHIE CLIP UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-12 for FILSHIE CLIP UNK manufactured by Cooper Surgical Inc..

Event Text Entries

[38538000] Filshie clips were used in my tubal ligation on (b)(6) 2010 during my awake c-section with my second child at age (b)(6). I immediately began having sharp stabbing pains to which my doctor dismissed that day. I was given iv pain meds as well as a pain pump to control the pain yet nothing helped. When my doctor came to see me the following day she prescribed percocet (despite my concern for my breastfeeding baby) and dismissed my pain yet again because i had a "rough delivery because the baby was so big. " my pain was constant and ranged from a sharp stabbing pain in my abdomen and lower back to an electrical sensation that shot down from my lower abdomen to my knees, rendering me incapable of carrying my child safely as the pain was so unbearable it would knock me to the floor. As time passed my pain dulled to a lower degree, but was still constant. The electrical sensation would still knock me to the floor. This pain went on for 14 months until i had a reversal in the hopes of relief. Upon waking from my successful open abdominal reversal, the constant pain in my lower abdomen and back had completely dissipated. The stabbing and electrical sensation never returned. My other symptoms which had developed and increased over the course of 14 months also started to heal. I had not related facial hair growth, loss of hair on my head and eyebrows to my tubal with filshie clips. There were many other symptoms i suffered from that. I had not realized were related to my tubal until my body began to heal over the course of a year and half.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5060254
• MDR Report Key: 5445168
• Date Received: 2016-02-12
• Date of Report: 2016-02-12
• Date of Event: 2010-07-28
• Date Added to Maude: 2016-02-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: FILSHIE CLIP
• Generic Name: FILSHIE CLIP
• Product Code: KNH
• Date Received: 2016-02-12
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Device Expiration Date: 2016-02-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL INC.

Device Sequence Number: 1

• Brand Name: FILSHIE CLIP
• Generic Name: FILSHIE CLIP
• Product Code: HGB
• Date Received: 2016-02-12
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Device Expiration Date: 2016-02-29
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPER SURGICAL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2016-02-12