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

Catalog Number 520350

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Prolapse (2475)

Event Type  Injury  

Event Description

According to the available information it was reported that during a patient examination, the doctor could feel what appeared to be an anchor that had detached or come out of the sacrous spinous ligament causing apical prolapse to recur.

• Brand Name: SAFFRON ANCHOR
• 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: 18394286
• MDR Text Key: 331328527
• Report Number: 2125050-2023-01648
• Device Sequence Number: 1
• Product Code: PBQ
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 520350
• Is the Reporter a Health Professional?: Yes
• 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