MAUDE Adverse Event Report: COOPERSURGICAL, INC. FILSHIE CLIPS / CLAMPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Swelling (2091)

Event Date 02/14/1996

Event Type  Injury  

Event Description

Was sterilized with filshie clips and having with them everyday since swelling and infections along with other problems.

• Brand Name: FILSHIE CLIPS / CLAMPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 8479503
• MDR Text Key: 141008436
• Report Number: MW5085542
• 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: 03/29/2019

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 91