• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COLOPLAST MANUFACTURING US, LLC Back to Search Results
Model Number 5195512400
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Dysuria (2684); Dyspareunia (4505)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
This event was previously reported under manufacturer report number 2125050-2019-00668. This report is intended to be a follow-up report to submit additional information that has been received. Any further information warranting a follow-up report will be submitted under this new manufacturer report number. Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
 
Event Description
Additional information received states between 3/3/2015 and 12/20/2018 vaginitis, vaginal discharge (bloody, thick white), abdominal cramping, dysuria, mesh erosion anterior vaginal wall. Partial excision of exposed sling on (b)(6) 2018, cystoscopy. In addition, pain, dyspareunia and urinary tract infections.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key11890442
MDR Text Key252910530
Report Number2125050-2021-00643
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number5195512400
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-