MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. HULKA CLIP; LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 10/31/2001

Event Type  Injury  

Event Description

On (b)(6) 2001 i had my tubes tied.For many years i suffered different symptoms and problems.After researching i had my tubes removed 12 ½ years later.The symptoms i was having and issues were a reaction to the hulka clip that was used.I knew my body even if doctors disagreed.It took me years to find one that listened.Fda safety report id # (b)(4).

• Brand Name: HULKA CLIP
• Type of Device: LAPROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.
• MDR Report Key: 9693873
• MDR Text Key: 179108877
• Report Number: MW5092897
• 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: 02/06/2020

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 59