MAUDE Adverse Event Report: FEMCARE LTD. ADNEXAL FILSHIE CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION

Device Problems Degraded (1153); Migration (4003)

Patient Problems Bacterial Infection (1735); Swelling/ Edema (4577)

Event Date 07/01/2020

Event Type  Injury  

Event Description

Reporter called on behalf of his wife to report an adverse event involving filshie clips she had implanted in 2010.Reporter stated that about 4 months ago, his wife developed a staph infection from the clips migrating and deteriorating inside her.Reporter stated his wife was on antibiotics for 2-3 weeks, and now she is starting to swell up again.Reporter stated he and his wife want the devices removed but are having problems with their surgeon.

• Brand Name: ADNEXAL FILSHIE CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION
• Manufacturer (Section D): FEMCARE LTD.
• MDR Report Key: 10786324
• MDR Text Key: 214802903
• Report Number: MW5097646
• Device Sequence Number: 1
• Product Code: KNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR