MAUDE Adverse Event Report: COLOPLAST A/S SAFFRON FIXATION TOOL; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE

Catalog Number 520340

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

According to the available information the anchor pulled out during suture placement check.

• Brand Name: SAFFRON FIXATION TOOL
• Type of Device: SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18325466
• MDR Text Key: 330489720
• Report Number: 2125050-2023-01596
• Device Sequence Number: 1
• Product Code: PBQ
• UDI-Device Identifier: 05708932757423
• UDI-Public: 05708932757423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520340
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1