MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION HULKA CLIP; LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number 4986.09

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

Patient Problems Abdominal Pain (1685); Unspecified Reproductive System or Breast Problem (4513); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

The exact date of implant is unknown.Patient said (b)(6) 2008 was entered.Patient information and patient history was not collected during the initial call.Rwmic will submit a follow-up report if and when new information is received.

Event Description

On (b)(6) 2021, patient (b)(6) called rwmic regarding a hulka clip implanted in (b)(6) 2008.(b)(6) stated having periodic symptoms of sharp, lingering pain in her abdomen.Pain in her navel to her vagina and from her vagina to her bottom.Symptoms developed shortly after the devices were implanted, she is seeking to have the hulka clips removed.(b)(6) also called rwmic to inquire about the hulka clip recall in 2009.(b)(6) had contacted her doctors office for her medical records but received incomplete information, lot number information was not available at her doctors office.

Event Description

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

Manufacturer Narrative

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.

• Brand Name: HULKA CLIP
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION; 353 corporate woods parkway; vernon hills IL 60061 3110
• Manufacturer Contact: lisa williams ; 353 corporate woods parkway; vernon hills, IL 60061-3110 ; 8479131113
• MDR Report Key: 13114422
• MDR Text Key: 288283577
• Report Number: 1418479-2021-00060
• 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: Other
• Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4986.09
• Device Catalogue Number: 4986.09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 06/07/2022
• 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): Other
• Patient Age: 23 YR
• Patient Sex: Female