FILSHIE CLIPS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-10 for FILSHIE CLIPS manufactured by Femcare Ltd..

Event Text Entries

[178764594] Migrated device. I had a tubal litigation with filshie clips in (b)(6) 2012. Not only was i not informed that the clips were placed, but the doctor never consulted my records or asked me if i had an allergy to metal. I found out just recently that im clinically allergic to nickel, filshie clips contain nickel, and one clip has migrated. Fda safety report id # (b)(4). Fda received date: 02/06/2020.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092886
• MDR Report Key: 9693647
• Date Received: 2020-02-10
• Date of Report: 2020-02-06
• Date of Event: 2020-01-21
• Date Added to Maude: 2020-02-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• 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: 3

Device Sequence Number: 1

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCULSION DEVICE
• Product Code: KNH
• Date Received: 2020-02-10
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Device Sequence Number: 2

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCULSION DEVICE
• Product Code: KNH
• Date Received: 2020-02-10
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Device Sequence Number: 3

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCULSION DEVICE
• Product Code: KNH
• Date Received: 2020-02-10
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Device Sequence Number: 4

• Brand Name: FILSHIE CLIPS
• Generic Name: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCULSION DEVICE
• Product Code: KNH
• Date Received: 2020-02-10
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: FEMCARE LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-02-10