MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION; HULKA CLIP

Model Number UNKNOWN

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems High Blood Pressure/ Hypertension (1908); Menstrual Irregularities (1959); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a retrospective review of all 2019 complaint files that rw mic is conducting.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

On november 19, 2019 richard wolf received a call from a patient requesting information regarding a hulka clip lawsuit.Patient indicated they had additional questions and provided contact information.Complaints specialist called the customer on november 20, 2019, and obtained the following information: patient has experienced high blood pressure, heavier menstrual cycle, and cramping during specific seasons since having the hulka clip implanted in (b)(6) of 2004.Patient was unable to provide part or batch information.Notes from the call: patient mentioned seeing something about a hulka clip recall.Complaints specialist verified with her whether it was the hulka clip or the flishie clip symptoms experienced: high blood pressure, heavy cycle, cramping during season, heavier in the pelvic area as it gets colder complaints specialist asked if she had a few minutes so that she, complaints specialist, could ask questions to complete the medwatch report.Patient was given the option to decline answering the questions.The device was implanted (b)(6) 2004.It has not been removed.Patient was approx.25 (unsure) years of age when it was implanted.Side effects: recent - high blood pressure, started maybe two years ago, around 29/30 years if age when side effects started.Medical intervention: no.Lab tests/data conducted due to side effects: no.Part/lot number: unknown.She is unsure if it (hulka clip) is the cause of what she is experiencing.Complaints specialist to check the history of the device to see if there have been any previous complaints and get back to patient.Complaints specialist mentioned not seeing any complaints in the past three years for the hulka clip.Patient has not reported this to the fda.Complaints specialist gave patient her contact information.As of 3/3/2022, we have not heard anything further from the patient.

Manufacturer Narrative

This mdr is being submitted as part of an ongoing retrospective review (remediation) of prior files by rwmic.Follow-up report #1 is to provide fda with new information.New information: the following fields have new information: h10.Because the device is implanted, it is practically impossible for the device to be returned and for that reason, we are unable to evaluate the device instead, a product history evaluation for hulka clip (4986.09, 4986.90, 4986.05) was completed.The hulka clip is an implantable device manufactured by richard wolf medical instrument corporation (rwmic).Between 2019 to the present, rwmic received a number of complaints from patients alleging problems with the hulka clip.See attached spreadsheet for complaints received from 2019 to the present.As part of the due diligence, the patients were asked to confirm with their medical provider that 1.The device they had implanted was, in fact, a hulka clip.2.The part number and lot/batch number of the device.To date, for the attached complaints, this information was not provided to rwmic.For that reason, rwmic is unable to verify whether or not the device implanted is the rwmic hulka clip.The associated patient information guide (e36e-11-03) and letter to physicians included with the hulka clip gives the potential risk to the patient.Potential risks: the most serious known potential adverse effect is ectopic pregnancy.Other adverse effects are pregnancy, abnormal menstrual patterns, infection, pain and trauma (bleeding).There is a minimal risk that the body might be allergic to such materials as metal or plastic, causing an infection or adhesion.As with any surgical procedure, surgical errors are possible and could include misapplication of the clip, and cutting of unintended tissue or organs.Other unusual risks, including fatality, are always possible, but are as rare as with any common operation.The procedure is not recommended for all women who don't want more children.Sometimes previous surgery, being overweight, or other medical problems may mean that another solution to her problem should be worked out.There will be no change in your normal hormone function or ministration since the ovaries are not damaged.Because the device is implanted, it is practically impossible for the device to be returned and for that reason, we are unable to evaluate the device.This memo replaces the product investigation report (5020) and/or the product history evaluation (5253).Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the product history evaluation.See manufacturers narrative (h10).

• Type of Device: HULKA CLIP
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION; 353 corporate woods pkwy; vernon hills IL 60061
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION; 353 corporate woods pkwy; vernon hills IL 60061
• Manufacturer Contact: colleen tobin ; 353 corporate woods pkwy; vernon hills, IL 60061 ; 8479550775
• MDR Report Key: 13733924
• MDR Text Key: 297033636
• Report Number: 1418479-2019-00062
• Device Sequence Number: 1
• Product Code: KNH
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American