MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC) HULKA CLIP

Model Number	4986.90
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/1993
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient had devices implanted in (b)(6) 1993 (two devices per package, one for each fallopian tube).Devices were not returned to manufacturer for investigation.During the time devices were implanted, patient reported having "health issues." no other information given (test results, doctor diagnosis.) richard wolf medical instruments corporation (rwmic) is unable to confirm complaint.There has been two similar complaints on this device in the last fifteen years, mdr1418479-2016-00009 & mdr1418479-2016-00012.Richard wolf medical instruments corporation (rwmic) considers this report closed.If any new information is received a follow up report will be submitted.
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received a phone call from a patient indicating she had a device implanted and now has "many health issues." patient reported having a tubal ligation in (b)(6) 1993 when devices were implanted (package contains two clips, one for each fallopian tube).

• Brand Name: HULKA CLIP
• Common Device Name: HULKA CLIP
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP (RWMIC); registration #1418479; 353 corporate woods parkway; vernon hills IL 60061 3110
• MDR Report Key: 6474246
• Report Number: 1418479-2017-00004
• Device Sequence Number: 371585
• Product Code: KNH
• UDI-Device Identifier: 00861523000102
• UDI-Public: 00861523000102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P870080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1993
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2017

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 Number: 4986.90
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2017
• Initial Report FDA Received Date: 04/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other