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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SAFFRON FIXATION TOOL; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE
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COLOPLAST A/S SAFFRON FIXATION TOOL; SOFT-TISSUE/MESH ANCHOR, NON-BIOABSORBABLE Back to Search Results
Catalog Number 520340
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2024
Event Type  malfunction  
Event Description
According to the available information the surgeon deployed the device and noted that it was difficult to remove after placing the anchor.After examining the device, it was concluded that the anchor deployer was bent and unable to withdraw back into handset.She opened another device and completed case.It was noted there was no injury to patient.
 
Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report, and capa.No ncs nor capas were identified at the time of search.
 
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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 Key18888095
MDR Text Key337469033
Report Number2125050-2024-00400
Device Sequence Number1
Product Code PBQ
UDI-Device Identifier05708932757423
UDI-Public05708932757423
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220420
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number520340
Device Lot Number8921908_5203401400
Is the Reporter a Health Professional? Yes
Date Device Manufactured03/29/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age71 YR
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