MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. HULKA CLIPS; TUBAL OCCLUDING DEVICE

Model Number 4986.90

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/31/2001

Event Type  Injury  

Manufacturer Narrative

Product information was not provided.The reporter will be contacted in an attempt to obtain additional information.Should additional information become available, a follow up will be provided.

Event Description

On march 02, 2020, richard wolf medical instruments corp.(rwmic) received medwatch report # mw5092897.The patient reported they had their tubes tied and for many years they suffered different symptoms and problems.Patient reported having tubes tied twelve and a half (12.5) years later and determined that the symptoms they were having and issues were a reaction to the hulka clip.

• Brand Name: HULKA CLIPS
• Type of Device: TUBAL OCCLUDING DEVICE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills, il
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills, il
• Manufacturer Contact: daisy ramos ; 353 corporate woods parkway; vernon hills, il ; 9131113227
• MDR Report Key: 9918527
• MDR Text Key: 186275329
• Report Number: 1418479-2020-00009
• Device Sequence Number: 1
• Product Code: KNH
• UDI-Device Identifier: 00861523000102
• UDI-Public: 00861523000102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2020

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?: No
• Device Operator: No Information
• Device Model Number: 4986.90
• Device Catalogue Number: 4986.09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention