MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK, WECK CLIP; CLIP, IMPLANTABLE

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Perforation (2001)

Event Date 02/01/2019

Event Type  Injury  

Event Description

Hem-o-lok clip weck clip has perforated my bladder 3 times over 2 years plus when i looked online it appears this happens more often than reported.No warning was made about this side effect but it is a known problem with urologists.I still have 5 more clips inside me, ticking time bombs.

• Brand Name: HEM-O-LOK, WECK CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8358979
• MDR Text Key: 137180677
• Report Number: MW5084172
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR
• Patient Weight: 103