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

Model Number 4986.90

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  

Event Description

Rwmic complaint (b)(4).Patient had hulka clip implanted in 2003 sometime after the birth of her son.Patient has been having unbearable menstrual periods.In trying to stop the bleeding, went through testing for fibroids and when she did a (b)(4) search, saw the hulka clip recall.Patient called rwmic on (b)(6) 2021 to inquire about the hulka clip recall and inquired about how to have them removed.The patient also informed us that she has problems with gold on her skin, certain amount of gold.Mdr awareness date: (b)(6) 2021.

Manufacturer Narrative

The exact date of implant is unknown.Patient said only reported the year 2003, so 01/01/2003 was entered.The hulka clip is an implantable device manufactured by richard wolf medical instrument corporation (rwmic).Rwmic has received a number of complaints from patients alleging problems with the hulka clip.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, 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 menstruation 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.Rwmic considers this mdr closed.Should new information become available, 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
• MDR Report Key: 15070469
• MDR Text Key: 296289393
• Report Number: 1418479-2022-00021
• 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
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4986.90
• Device Catalogue Number: 4986.90
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2021
• 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: 21 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: Black Or African American