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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. HULKA CLIPS; TUBAL OCCLUDING DEVICE
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RICHARD WOLF MEDICAL INSTRUMENTS CORP. HULKA CLIPS; TUBAL OCCLUDING DEVICE Back to Search Results
Model Number 4986.90
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 10/31/2001
Type of Reportable Event Serious Injury
Additional 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 or Problem 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.
 
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Brand Name
HULKA CLIPS
Common Device Name
TUBAL OCCLUDING DEVICE
Manufacturer (Section D)
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods parkway
vernon hills, il
MDR Report Key9918527
Report Number1418479-2020-00009
Device Sequence Number3375261
Product Code KNH
UDI-Device Identifier00861523000102
UDI-Public00861523000102
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P870080
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2001
Device Explanted Year2013
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Model Number4986.90
Device Catalogue Number4986.09
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/02/2020
Initial Report FDA Received Date04/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Other; Required Intervention;
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